Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
2 other identifiers
interventional
5,614
30 countries
375
Brief Summary
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2008
Longer than P75 for phase_3
375 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
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
April 10, 2014
CompletedApril 21, 2014
April 1, 2014
4.7 years
March 20, 2008
March 4, 2014
April 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).
Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)
Secondary Outcomes (20)
Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
- +15 more secondary outcomes
Study Arms (2)
Apixaban
ACTIVE COMPARATORapixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
Enoxaparin + Warfarin
EXPERIMENTALEnoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
Interventions
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Eligibility Criteria
You may qualify if:
- Men and women ≥ 18 years of age
- Clinical diagnosis of DVT or PE
You may not qualify if:
- Contraindications for enoxaparin or warfarin
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Significantly impaired kidney or liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (381)
Alabama Clinical Therapeutics, Llc
Birmingham, Alabama, 35235, United States
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
Fort Smith Lung Center
Fort Smith, Arkansas, 72901, United States
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205, United States
Beaver Medical Group
Banning, California, 92220, United States
University Of California San Francisco-Fresno
Fresno, California, 93701, United States
University Of California, Davis Medical Center
Sacramento, California, 95817, United States
Chest Medicine & Critical Care Medical Gr. Inc.
San Diego, California, 92123, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Harbor Ucla Medical Center
Torrance, California, 90509, United States
New West Physicians
Golden, Colorado, 80401, United States
Drogue Medical, Llc
Wheat Ridge, Colorado, 80033, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med
New Haven, Connecticut, 06510, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Bay Pines Va Healthcare Systems
Bay Pines, Florida, 33744, United States
Daniel G. Lorch, Jr, Md, Cpi
Brandon, Florida, 33511, United States
Research Alliance, Inc.
Clearwater, Florida, 33756, United States
River City Clinical Research
Jacksonville, Florida, 32207, United States
Pasadena Center For Medical Research
St. Petersburg, Florida, 33707, United States
Tampa Clinical Research
Tampa, Florida, 33624, United States
Office Of Michele S. Maholtz Md
Vero Beach, Florida, 32960, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Atlanta Pulmonary Group
Atlanta, Georgia, 30342, United States
Atlanta Institute For Medical Research, Inc
Decatur, Georgia, 30030, United States
Chatham Hospitalists
Savannah, Georgia, 31405, United States
Gateway Cardiology. P.C
Jerseyville, Illinois, 62052, United States
West Suburban Medical Center
Oak Park, Illinois, 60302, United States
Infectious Disease Of Indiana Psc
Carmel, Indiana, 46032, United States
Heartland Vascular Medicine And Surgery
Windsor Heights, Iowa, 50324, United States
Kentucky Lung Clinic
Hazard, Kentucky, 41701, United States
Univ. Of Kentucky Dept. Of Surgery
Lexington, Kentucky, 40536, United States
Research Integrity, Llc
Owensboro, Kentucky, 42303, United States
Pen Bay Medical Center
Rockport, Maine, 04856, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
Medstar Research Health Institute
Baltimore, Maryland, 21237, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Mississippi Medical Research, Llc
Picayune, Mississippi, 39466, United States
University Of Missouri-Columbia
Columbia, Missouri, 65212, United States
Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
St. John'S Mercy Medical Center
St Louis, Missouri, 63141, United States
Mercury Street Medical Group, Pllc
Butte, Montana, 59701, United States
Great Falls Clinic, Llp
Great Falls, Montana, 59405, United States
Internal Medical Associates Of Grand Island, P.C
Grand Island, Nebraska, 68803, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Pulmonary & Critical Care Services, Pc
Albany, New York, 12205, United States
Kaleida Health System
Buffalo, New York, 14209, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
New York Medical College
Valhalla, New York, 10595, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Wilmington Medical Research
Wilmington, North Carolina, 28401, United States
Clinical Trials Of America, Inc.
Winston-Salem, North Carolina, 27103, United States
Altru Health System Clinic
Grand Forks, North Dakota, 58201, United States
Huron Hospital
Cleveland, Ohio, 44112, United States
Remington Davis Inc.
Columbus, Ohio, 43215, United States
Oregon Health Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Greenville Hospital System
Greenville, South Carolina, 29615, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Kore Cv Research
Jackson, Tennessee, 38305, United States
Primecare Medical Group
Houston, Texas, 77024, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, 78229, United States
University Of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Lake Washington Vascular, Pllc
Bellevue, Washington, 98004, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
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Hradec Králové, 500 05, Czechia
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Arhus C, 8000, Denmark
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Mannheim, 68161, Germany
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Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
PMID: 35570249DERIVEDCohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22.
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PMID: 23808982DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 26, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 21, 2014
Results First Posted
April 10, 2014
Record last verified: 2014-04