A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
COMMANDER HF
A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
3 other identifiers
interventional
5,081
31 countries
537
Brief Summary
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Sep 2013
Longer than P75 for phase_3 heart-failure
537 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedStudy Start
First participant enrolled
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2018
CompletedResults Posted
Study results publicly available
May 10, 2019
CompletedMay 10, 2019
April 1, 2019
4.6 years
June 12, 2013
April 18, 2019
April 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient \[pt\]-year \[yr\]) = 100\*n/(total risk exposure), where n is the number of events.
Up to Global treatment end date (approximately 54 months)
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Up to 227 Weeks
Secondary Outcomes (7)
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
Up to Global treatment end date (approximately 54 months)
Event Rate of Cardio Vascular Death
Up to Global treatment end date (approximately 54 months)
Event Rate of Re-Hospitalization for Worsening of Heart Failure
Up to Global treatment end date (approximately 54 months)
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
Up to Global treatment end date (approximately 54 months)
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
Up to Global treatment end date (approximately 54 months)
- +2 more secondary outcomes
Study Arms (2)
Rivaroxaban 2.5 mg
EXPERIMENTALEach participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Placebo
PLACEBO COMPARATOREach participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Interventions
Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
Eligibility Criteria
You may qualify if:
- Must have symptomatic heart failure for at least 3 months prior to Screening
- Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay \[that is, staying past midnight\] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
- Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
- Must have evidence of significant coronary artery disease
- Must be medically stable in terms of their heart failure clinical status at the time of randomization
- Must have a brain natriuretic peptide (BNP) level greater than or equal to (\>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level \>=800 pg/mL (preferred assay) during the Screening period and before randomization
You may not qualify if:
- Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
- Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
- Prior stroke within 90 days of randomization
- Has been hospitalized for longer than 21 days during the index event
- Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Bayercollaborator
Study Sites (563)
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Anchorage, Alaska, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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El Cajon, California, United States
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Glendale, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Atlantis, Florida, United States
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Daytona Beach, Florida, United States
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Jupiter, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Wellington, Florida, United States
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Winter Haven, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Cumming, Georgia, United States
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Macon, Georgia, United States
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Tucker, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Fairview Heights, Illinois, United States
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Peoria, Illinois, United States
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Rockford, Illinois, United States
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Urbana, Illinois, United States
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Anderson, Indiana, United States
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Indianapolis, Indiana, United States
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Merrillville, Indiana, United States
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Munster, Indiana, United States
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South Bend, Indiana, United States
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Iowa City, Iowa, United States
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Bossier City, Louisiana, United States
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Hammond, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Biddeford, Maine, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Randallstown, Maryland, United States
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Bay City, Michigan, United States
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Grand Blanc, Michigan, United States
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Mount Clemens, Michigan, United States
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Pontiac, Michigan, United States
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Ypsilanti, Michigan, United States
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Saint Paul, Minnesota, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Washington, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Bridgewater, New Jersey, United States
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Elmer, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Manalapan, New Jersey, United States
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Ridgewood, New Jersey, United States
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Sewell, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Jamaica, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Pinehurst, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Fairfield, Ohio, United States
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Kettering, Ohio, United States
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Bartlesville, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Doylestown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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York, Pennsylvania, United States
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Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Nashville, Tennessee, United States
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Cypress, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Huntsville, Texas, United States
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Kingwood, Texas, United States
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Lubbock, Texas, United States
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McKinney, Texas, United States
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Burlington, Vermont, United States
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Newport News, Virginia, United States
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Bellingham, Washington, United States
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Tacoma, Washington, United States
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Huntington, West Virginia, United States
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Bahía Blanca, Argentina
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Buenos Aires, Argentina
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Caba, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Merlo, Argentina
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Quilmes, Argentina
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Resistencia, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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San Nicolás, Argentina
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Santa Fe, Argentina
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Santiago del Estero, Argentina
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Vicente López, Argentina
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Bedford, Australia
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Cairns, Australia
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Concord, Australia
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Darlinghurst, Australia
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Hobart, Australia
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Launceston, Australia
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Perth, Australia
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Sydney, Australia
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Wollongong, Australia
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Woolloongabba, Australia
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Belém, Brazil
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Belo Horizonte, Brazil
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Blumenal, Brazil
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Brasília, Brazil
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Campina Grande do Sul, Brazil
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Campinas, Brazil
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Campo Grande, Brazil
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Canoas, Brazil
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Curitiba, Brazil
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Goiânia, Brazil
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Marília, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Jose Do Rio Preto, Brazil
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São Paulo, Brazil
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São Pedro, Brazil
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Tatuí, Brazil
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Uberlândia, Brazil
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Votuporanga, Brazil
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Blagoevgrad, Bulgaria
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Burgas, Bulgaria
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Dimitrovgrad, Bulgaria
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Kazanlak, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Edmonton, Alberta, Canada
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Maple Ridge, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Cambridge, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Baotou, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Daqing, China
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Guangzhou, China
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Haikou, China
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Hangzhou, China
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Hunan, China
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Jinan, China
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Jining, China
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Lanzhou, China
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Nanchang, China
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Nanjing, China
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Nanning, China
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Qingdao, China
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Shanghai, China
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Shenyang, China
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Shijiazhuang, China
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Suzhou, China
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Taiyuan, China
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Tianjin, China
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Wuhan, China
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Xi'an, China
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Yangzhou, China
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Yichang, China
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Brno, Czechia
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Hodonín, Czechia
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Hradec Králové, Czechia
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Hranice, Czechia
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Karlovy Vary, Czechia
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Kladno, Czechia
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Kolín, Czechia
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Litomyšl, Czechia
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Mladá Boleslav, Czechia
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Olomouc, Czechia
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Plze?-Bory, Czechia
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Prague, Czechia
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Praha 8 - Libe?, Czechia
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Slaný, Czechia
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Teplice, Czechia
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Uherské Hradišt?, Czechia
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Valašské Mezi?í?í, Czechia
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Esbjerg, Denmark
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Herlev, Denmark
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Hjørring, Denmark
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Hvidovre, Denmark
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Køge, Denmark
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Tallinn, Estonia
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Besançon, France
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Bron, France
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Chambray-lès-Tours, France
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Corbeil-Essonnes, France
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Lille, France
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Montpellier, France
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Nantes, France
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Nice, France
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Pau, France
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Rouen, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Berlin, Germany
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Bielefeld, Germany
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Bonn, Germany
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Coburg, Germany
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Dresden, Germany
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Halle, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Konstanz, Germany
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Langen, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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Magdeburg, Germany
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Mainz, Germany
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Markkleeberg, Germany
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Papenburg, Germany
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Stuttgart, Germany
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Ulm, Germany
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Witten, Germany
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Athens, Greece
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Heraklion -Crete, Greece
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Larissa, Greece
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Thessalonikis, Greece
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Voula, Greece
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Balatonfüred, Hungary
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Berettyóújfalu, Hungary
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Budapest, Hungary
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Győr, Hungary
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Miskolc, Hungary
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Nagykanizsa, Hungary
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Szekszárd, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Zalaegerszeg, Hungary
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Aichi, Japan
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Chiba, Japan
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Chikushino-shi, Japan
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Ehime, Japan
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Fukuoka, Japan
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Gifu, Japan
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Gunma, Japan
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Hatsukaichi, Japan
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Hitachi, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Izumo, Japan
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Kagawa, Japan
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Kahoku-District, Japan
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Kanagawa, Japan
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Kobe, Japan
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Komatsushima-shi, Japan
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Koshigaya-shi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Niigata, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Sapporo, Japan
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Sendai, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, Japan
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Tachikawa, Japan
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Takaraduka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Toyama, Japan
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Toyoake, Japan
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Tsu, Japan
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Wakayama, Japan
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Yamaguchi, Japan
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Yatsushiro, Japan
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Yokohama, Japan
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Yonago, Japan
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Daugavpils, Latvia
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Kuldīga, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Sigulda, Latvia
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Ventspils, Latvia
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Panevezys, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Cheras, Malaysia
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George Town, Malaysia
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Johor Bahru, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Selangor, Malaysia
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Kuching, Malaysia
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Selayang Baru Utara, Malaysia
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Aguascalientes, Mexico
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Benito Juárez, Mexico
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Chihuahua City, Mexico
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Culiacán, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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León, Mexico
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Mexico City, Mexico
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México, Mexico
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Oaxaca City, Mexico
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Pachuca, Mexico
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Puebla City, Mexico
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Querétaro, Mexico
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San Luis Potosí City, Mexico
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Tampico, Mexico
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Veracruz, Mexico
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Almere Stad, Netherlands
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Amsterdam, Netherlands
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Blaricum, Netherlands
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Breda, Netherlands
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Deventer, Netherlands
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Doetinchem, Netherlands
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Ede, Netherlands
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Groningen, Netherlands
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Heerlen, Netherlands
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Helmond, Netherlands
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Maastricht, Netherlands
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Meppel, Netherlands
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Tilburg, Netherlands
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Będzin, Poland
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Gdynia, Poland
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Gliwice, Poland
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Grodzisk Mazowiecki, Poland
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Inowrocław, Poland
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Katowice, Poland
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Kielce, Poland
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Krakow, Poland
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Kutno, Poland
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Lodz, Poland
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Lubin, Poland
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Lublin, Poland
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Myślenice, Poland
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Olsztyn, Poland
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Ostrowiec Świętokrzyski, Poland
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Ostrołęka, Poland
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Oświęcim, Poland
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Puławy, Poland
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Płock, Poland
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Rabka-Zdrój, Poland
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Skierniewice, Poland
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Starogard Gdański, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Włocławek, Poland
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Zabrze, Poland
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Zamość, Poland
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Łódż, Poland
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Almada, Portugal
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Aveiro, Portugal
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Braga, Portugal
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Carnaxide, Portugal
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Coimbra, Portugal
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Covilha, Portugal
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Leiria, Portugal
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Lisbon, Portugal
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Matosinhos Municipality, Portugal
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Viana do Castelo, Portugal
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Vila Real, Portugal
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Bacau, Romania
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Baia Mare, Romania
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Brasov, Romania
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Brăila, Romania
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Bucharest, Romania
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Buzău, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Focşani, Romania
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Galati, Romania
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Iași, Romania
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Oradea, Romania
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Piteşti, Romania
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Sibiu, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Barnaul, Russia
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Chita, Russia
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Ivanovo, Russia
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Izhevsk, Russia
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Kaluga, Russia
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Kemerovo, Russia
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Kirov, Russia
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Krasnoyarsk, Russia
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Kursk, Russia
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Moscow, Russia
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Moscow, Zelenograd, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Orenburg, Russia
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Perm, Russia
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Rostov-on-Don, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Syktyvkar, Russia
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Tomsk, Russia
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Tyumen, Russia
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Voronezh, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Banská Bystrica, Slovakia
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Bardejov, Slovakia
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Košice, Slovakia
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Lučenec, Slovakia
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Moldava nad Bodvou, Slovakia
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Nitra, Slovakia
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Považská Bystrica, Slovakia
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Svidník, Slovakia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Centurion, South Africa
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Durban, South Africa
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Pinelands, South Africa
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Pretoria, South Africa
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Tongaat, South Africa
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Busan, South Korea
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Cheongju-si, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Gwangju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Wŏnju, South Korea
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A Coruña, Spain
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Alicante, Spain
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Almería, Spain
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Ávila, Spain
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Barcelona, Spain
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Burgos, Spain
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Cáceres, Spain
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Elche, Spain
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Granada, Spain
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Lorca, Spain
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Madrid, Spain
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Majadahonda, Spain
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Murcia, Spain
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Olot, Spain
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Orihuela, Spain
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Palma de Mallorca, Spain
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San Juan, Spain
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Sanlúcar de Barrameda, Spain
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Sant Joan Despí, Spain
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Santander, Spain
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Seville, Spain
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Terrassa, Spain
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Torrevieja, Spain
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Valencia, Spain
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Vigo, Spain
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Viladecans, Spain
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Falun, Sweden
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Jönköping, Sweden
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Ljungby, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Eskişehir, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Kahramanmaraş, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Kırıkkale, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Sivas, Turkey (Türkiye)
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Cherkassy, Ukraine
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Cherkasy, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Vinnitsa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
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Zaporizhzhya, Ukraine
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Zhytomyr, Ukraine
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Aberdeen, United Kingdom
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Airdrie, United Kingdom
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Birmingham, United Kingdom
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Chesterfield, United Kingdom
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Chichester, United Kingdom
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Clydebank, United Kingdom
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Cottingham, United Kingdom
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Dudley, United Kingdom
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Dundee, United Kingdom
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East Kilbride, United Kingdom
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Exeter, United Kingdom
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Inverness, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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TA1 5DA, United Kingdom
Related Publications (7)
Sharma A, Caldeira D, Razaghizad A, Pinto FJ, van Veldhuisen DJ, Mehra MR, Lam CSP, Cleland J, Anker SD, Greenberg B, Ferreira JP, Zannad F. Cardiovascular effects of rivaroxaban in heart failure patients with sinus rhythm and coronary disease with and without diabetes: a retrospective international cohort study from COMMANDER-HF. BMJ Open. 2023 Aug 11;13(8):e068865. doi: 10.1136/bmjopen-2022-068865.
PMID: 37567750DERIVEDFerreira JP, Cleland JG, Lam CSP, Anker SD, Mehra MR, van Veldhuisen DJ, Byra WM, La Police DA, Pitt B, Greenberg B, Zannad F. Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE. Clin Res Cardiol. 2021 Oct;110(10):1554-1563. doi: 10.1007/s00392-021-01830-1. Epub 2021 Mar 8.
PMID: 33686472DERIVEDFerreira JP, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, La Police DA, Anker SD, Mehra MR, Leroy C, Eschwege V, Toussaint-Hacquard M, Rossignol P, Greenberg B, Zannad F. Impact of Geographic Region on the COMMANDER-HF Trial. JACC Heart Fail. 2021 Mar;9(3):201-211. doi: 10.1016/j.jchf.2020.11.007. Epub 2021 Feb 3.
PMID: 33549557DERIVEDCunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.
PMID: 32171760DERIVEDMehra MR, Vaduganathan M, Fu M, Ferreira JP, Anker SD, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, Spiro TE, Deng H, Zannad F, Greenberg B. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. Eur Heart J. 2019 Nov 21;40(44):3593-3602. doi: 10.1093/eurheartj/ehz427.
PMID: 31461239DERIVEDGreenberg B, Neaton JD, Anker SD, Byra WM, Cleland JGF, Deng H, Fu M, La Police DA, Lam CSP, Mehra MR, Nessel CC, Spiro TE, van Veldhuisen DJ, Vanden Boom CM, Zannad F. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Jun 1;4(6):515-523. doi: 10.1001/jamacardio.2019.1049.
PMID: 31017637DERIVEDZannad F, Anker SD, Byra WM, Cleland JGF, Fu M, Gheorghiade M, Lam CSP, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.
PMID: 30146935DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SENIOR DIRECTOR, CLINICAL LEADER CV
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 14, 2013
Study Start
September 10, 2013
Primary Completion
April 19, 2018
Study Completion
April 19, 2018
Last Updated
May 10, 2019
Results First Posted
May 10, 2019
Record last verified: 2019-04