Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
CHANGE-AFIB
Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation
1 other identifier
interventional
339
1 country
103
Brief Summary
While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected AF. In usual care, these patients are started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) along with stroke prevention therapy. The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved cardiovascular outcomes and quality of life in patients first-detected AF. The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score. The treatment follow-up period will be 12 months. There will be two follow-up visits. Consistent with the pragmatic nature of the trial, the first follow-up will occur between 3 -9 months and the 2nd will occur at 12 months (with a window of +/- 30 days). Approximately 3000 patients will be enrolled and randomly assigned (1:1) to study intervention. The study intervention will be dronedarone 400 mg twice daily in addition to usual care versus usual care alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 atrial-fibrillation
Started Oct 2021
103 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
October 27, 2021
CompletedStudy Start
First participant enrolled
October 29, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 28, 2025
January 1, 2025
2.3 years
October 27, 2021
January 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular Hospitalization or Death
First occurrence of unplanned CV hospitalization or death from any cause within 12 months of randomization. All unplanned hospitalizations (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) for cardiovascular causes will be considered a cardiovascular hospitalization.
Evaluated through 12 months from randomization
Secondary Outcomes (7)
Win Ratio
Evaluated through 12 months from randomization
All-cause mortality
Evaluated through 12 months from randomization
Ischemic stroke or systemic embolism
Evaluated through 12 months from randomization
Hospitalization for new/worsening diagnosis of heart failure
Evaluated through 12 months from randomization
Hospitalization for acute coronary syndrome
Evaluated through 12 months from randomization
- +2 more secondary outcomes
Other Outcomes (7)
Any unplanned arrhythmia-related hospitalization
Evaluated through 12 months from randomization
Number of participants who experience AF progression
Evaluated through 12 months from randomization
Number of participants who undergo cardioversion (pharmacologic or electrical)
Evaluated through 12 months from randomization
- +4 more other outcomes
Study Arms (2)
Dronedarone
EXPERIMENTALIn most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the United States Prescribing Information (USPI) when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.
Usual care
NO INTERVENTIONIn most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.
Interventions
Dronedarone 400 mg twice daily in addition to usual care
Eligibility Criteria
You may qualify if:
- Age \>=21 years.
- First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days).
- Electrocardiographic documentation of atrial fibrillation.
- Estimated life expectancy of at least 1 year.
- Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
You may not qualify if:
- \. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (\>7 days) antiarrhythmic drug therapy.
- \. Planned cardiothoracic surgery. 4. New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks.
- \. Patients with reduced ejection fraction (LVEF ≤40%). 6. Permanent atrial fibrillation. 7. Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men.
- \. Bradycardia with a resting heart rate \< 50 bpm 9. PR interval \>280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device.
- \. Corrected QT interval \>=500 msec. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Heart Associationlead
- Duke Clinical Research Institutecollaborator
- Sanoficollaborator
Study Sites (103)
Thomas Hospital
Fairhope, Alabama, 36532, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260, United States
Los Angeles Medical Center (Kaiser Permenente)
Los Angeles, California, 90027, United States
West Los Angeles Medical Center
Los Angeles, California, 90034, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UC Irvine Medical Center (AKA UCI Health)
Orange, California, 92868, United States
Los Robles Health System - Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
UCLA Medical Center - Harbor
Torrance, California, 90502, United States
Colorado Heart & Vascular Group - St. Anthony's Hospital
Lakewood, Colorado, 80228, United States
Colorado Heart & Vascular Group - St. Anthony's North Health Campus
Westminster, Colorado, 80023, United States
Christiana Hospital
Newark, Delaware, 19718, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
Enmanuel Advanced Research Center, LLC
Miami, Florida, 33126, United States
Life Spring Research Foundation, LLC
Miami, Florida, 33130, United States
Nouvelle Clinical Research LLC
Miami, Florida, 33130, United States
Golden Touch Clinical Research
Miami, Florida, 33144, United States
Excellence Medical And Research, LLC
Miami, Florida, 33169, United States
The Miami Research Group
Miami, Florida, 33186, United States
Ocean Wellness Center, LLC
Miami Gardens, Florida, 33169, United States
Pharma Medical Innovations
Miami Lakes, Florida, 33014, United States
The Angel Medical Research
Miami Lakes, Florida, 33156, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia, 31201, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30062, United States
Mt Sinai Hospital Medical Center
Chicago, Illinois, 60608, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Hospital
Chicago, Illinois, 60612, United States
Riverside Medical Center
Kankakee, Illinois, 60901, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Captain James A Lovell Federal Health Care Center
North Chicago, Illinois, 60064, United States
Proctor Community Hospital
Peoria, Illinois, 61614, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Trinity Rock Island
Rock Island, Illinois, 61201, United States
St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. Francis
Springfield, Illinois, 62769, United States
St. John's Hospital of the Hospital Sisters of the Third Order of St. Francis
Springfield, Illinois, 62769, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Parkview Hospital, Inc.
Fort Wayne, Indiana, 46845, United States
Ascension St Vincent Hospital - Indianapolis
Indianapolis, Indiana, 46260, United States
Kansas City Heart and Vascular Specialists at Providence Medical Center
Kansas City, Kansas, 66112, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Baptist Health Lexington
Lexington, Kentucky, 40223, United States
Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Adventist Healthcare Shady Grove Medical Center
Rockville, Maryland, 20850, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
McLaren Bay Region
Bay City, Michigan, 48708, United States
DMC Harper University Hospital (AKA Wayne State University Hospital)
Detroit, Michigan, 48201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
Trinity Health Ann Arbor Hospital - Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
University Hospital - University of Missouri
Columbia, Missouri, 65211, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Barnes-Jewish Hospital (AKA Washington Univ)
St Louis, Missouri, 63110, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110, United States
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, Nebraska, 68124, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Albany Medical Center
Albany, New York, 12208, United States
NewYork-Presbyterian/Columbia University Irving Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering
New York, New York, 10065, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, 11758, United States
NYC Health and Hospitals - Lincoln
The Bronx, New York, 10451, United States
NYC Health and Hospitals - Jacobi
The Bronx, New York, 10461, United States
NYC Health and Hospitals - North Central Bronx
The Bronx, New York, 10467, United States
Duke University Hospital
Durham, North Carolina, 27705, United States
Durham VA Health Care System
Durham, North Carolina, 27705, United States
WakeMed Raleigh Campus
Raleigh, North Carolina, 27610, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28411, United States
Trinity Hospital
Minot, North Dakota, 58702, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
Kettering Health Dayton
Dayton, Ohio, 45405, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
McLaren - St Lukes Hospital
Maumee, Ohio, 43537, United States
Wooster Community Hospital Health System
Wooster, Ohio, 44691, United States
Oklahoma City VA Health Care System
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Health Holy Spirit Medical Center
Camp Hill, Pennsylvania, 17011, United States
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Penn State Health St Joseph Medical Center - Main Campus
Reading, Pennsylvania, 19605, United States
Ascension Saint Thomas Midtown
Nashville, Tennessee, 37236, United States
Ascension Seton Medical Center Austin
Austin, Texas, 78723, United States
Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth)
Fort Worth, Texas, 76104, United States
Memorial Hermann - Texas Medical Center
Houston, Texas, 77030, United States
Texas Institute of Cardiology
McKinney, Texas, 75071, United States
Synapse Clinical Research
Missouri City, Texas, 77549, United States
University Hospital at University of Texas San Antonio
San Antonio, Texas, 78229, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Chippenham and Johnston Willis Medical Center
Richmond, Virginia, 23225, United States
Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center)
Richmond, Virginia, 23249, United States
JW Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
Mayo Clinic Hospital - Franciscan Healthcare La Crosse
La Crosse, Wisconsin, 54601, United States
UW Health at the American Center (AKA UW Health East Madison Hospital)
Madison, Wisconsin, 53718, United States
University Hospital - University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Weston, Wisconsin, 54476, United States
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PMID: 39423993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan P Piccini, MD, MHS
Duke Clinical Research Organization
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2021
First Posted
November 23, 2021
Study Start
October 29, 2021
Primary Completion
January 31, 2024
Study Completion
June 30, 2024
Last Updated
January 28, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share