Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
Public ClinicalTrials.gov record NCT05130268. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05130268
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 339 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2021 (Actual)
- Primary completion
- Jan 31, 2024 (Actual)
- Completion
- Jun 30, 2024 (Actual)
- Last update posted
- Jan 28, 2025
2021 – 2024
United States locations
- U.S. sites
- 103
- U.S. states
- 31
- U.S. cities
- 81
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Thomas Hospital | Fairhope | Alabama | 36532 | — |
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | — |
| HonorHealth Scottsdale Shea Medical Center | Scottsdale | Arizona | 85260 | — |
| Los Angeles Medical Center (Kaiser Permenente) | Los Angeles | California | 90027 | — |
| West Los Angeles Medical Center | Los Angeles | California | 90034 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| UC Irvine Medical Center (AKA UCI Health) | Orange | California | 92868 | — |
| Los Robles Health System - Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | — |
| UCLA Medical Center - Harbor | Torrance | California | 90502 | — |
| Colorado Heart & Vascular Group - St. Anthony's Hospital | Lakewood | Colorado | 80228 | — |
| Colorado Heart & Vascular Group - St. Anthony's North Health Campus | Westminster | Colorado | 80023 | — |
| Christiana Hospital | Newark | Delaware | 19718 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | — |
| Enmanuel Advanced Research Center, LLC | Miami | Florida | 33126 | — |
| Life Spring Research Foundation, LLC | Miami | Florida | 33130 | — |
| Nouvelle Clinical Research LLC | Miami | Florida | 33130 | — |
| Golden Touch Clinical Research | Miami | Florida | 33144 | — |
| Excellence Medical And Research, LLC | Miami | Florida | 33169 | — |
| The Miami Research Group | Miami | Florida | 33186 | — |
| Ocean Wellness Center, LLC | Miami Gardens | Florida | 33169 | — |
| Pharma Medical Innovations | Miami Lakes | Florida | 33014 | — |
| The Angel Medical Research | Miami Lakes | Florida | 33156 | — |
| Northside Hospital | St. Petersburg | Florida | 33709 | — |
| Guardian Angel Research Center | Tampa | Florida | 33614 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Georgia Arrhythmia Consultants and Research Institute | Macon | Georgia | 31201 | — |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30062 | — |
| Mt Sinai Hospital Medical Center | Chicago | Illinois | 60608 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital | Chicago | Illinois | 60612 | — |
| Riverside Medical Center | Kankakee | Illinois | 60901 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Captain James A Lovell Federal Health Care Center | North Chicago | Illinois | 60064 | — |
| Proctor Community Hospital | Peoria | Illinois | 61614 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| Trinity Rock Island | Rock Island | Illinois | 61201 | — |
| St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. Francis | Springfield | Illinois | 62769 | — |
| St. John's Hospital of the Hospital Sisters of the Third Order of St. Francis | Springfield | Illinois | 62769 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Parkview Hospital, Inc. | Fort Wayne | Indiana | 46845 | — |
| Ascension St Vincent Hospital - Indianapolis | Indianapolis | Indiana | 46260 | — |
| Kansas City Heart and Vascular Specialists at Providence Medical Center | Kansas City | Kansas | 66112 | — |
| Overland Park Regional Medical Center | Overland Park | Kansas | 66215 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40223 | — |
| Saint Joseph Hospital | Lexington | Kentucky | 40504 | — |
| Heart Clinic of Hammond | Hammond | Louisiana | 70403 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Luminis Health Anne Arundel Medical Center | Annapolis | Maryland | 21401 | — |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | — |
| Adventist Healthcare Shady Grove Medical Center | Rockville | Maryland | 20850 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| McLaren Bay Region | Bay City | Michigan | 48708 | — |
| DMC Harper University Hospital (AKA Wayne State University Hospital) | Detroit | Michigan | 48201 | — |
| Sparrow Hospital | Lansing | Michigan | 48912 | — |
| McLaren Macomb | Mount Clemens | Michigan | 48043 | — |
| Trinity Health Ann Arbor Hospital - Michigan Heart | Ypsilanti | Michigan | 48197 | — |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | — |
| University Hospital - University of Missouri | Columbia | Missouri | 65211 | — |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | — |
| Barnes-Jewish Hospital (AKA Washington Univ) | St Louis | Missouri | 63110 | — |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63110 | — |
| CHI Health Creighton University Medical Center - Bergan Mercy | Omaha | Nebraska | 68124 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| NewYork-Presbyterian/Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering | New York | New York | 10065 | — |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758 | — |
| NYC Health and Hospitals - Lincoln | The Bronx | New York | 10451 | — |
| NYC Health and Hospitals - Jacobi | The Bronx | New York | 10461 | — |
| NYC Health and Hospitals - North Central Bronx | The Bronx | New York | 10467 | — |
| Duke University Hospital | Durham | North Carolina | 27705 | — |
| Durham VA Health Care System | Durham | North Carolina | 27705 | — |
| WakeMed Raleigh Campus | Raleigh | North Carolina | 27610 | — |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28411 | — |
| Trinity Hospital | Minot | North Dakota | 58702 | — |
| The MetroHealth System | Cleveland | Ohio | 44109 | — |
| Kettering Health Dayton | Dayton | Ohio | 45405 | — |
| Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| McLaren - St Lukes Hospital | Maumee | Ohio | 43537 | — |
| Wooster Community Hospital Health System | Wooster | Ohio | 44691 | — |
| Oklahoma City VA Health Care System | Oklahoma City | Oklahoma | 73104 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Penn State Health Holy Spirit Medical Center | Camp Hill | Pennsylvania | 17011 | — |
| Penn State Health Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Penn State Health St Joseph Medical Center - Main Campus | Reading | Pennsylvania | 19605 | — |
| Ascension Saint Thomas Midtown | Nashville | Tennessee | 37236 | — |
| Ascension Seton Medical Center Austin | Austin | Texas | 78723 | — |
| Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth) | Fort Worth | Texas | 76104 | — |
| Memorial Hermann - Texas Medical Center | Houston | Texas | 77030 | — |
| Texas Institute of Cardiology | McKinney | Texas | 75071 | — |
| Synapse Clinical Research | Missouri City | Texas | 77549 | — |
| University Hospital at University of Texas San Antonio | San Antonio | Texas | 78229 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Chippenham and Johnston Willis Medical Center | Richmond | Virginia | 23225 | — |
| Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center) | Richmond | Virginia | 23249 | — |
| JW Ruby Memorial Hospital | Morgantown | West Virginia | 26506 | — |
| Mayo Clinic Hospital - Franciscan Healthcare La Crosse | La Crosse | Wisconsin | 54601 | — |
| UW Health at the American Center (AKA UW Health East Madison Hospital) | Madison | Wisconsin | 53718 | — |
| University Hospital - University of Wisconsin-Madison | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center | Marshfield | Wisconsin | 54449 | — |
| Marshfield Medical Center | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05130268, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2025 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05130268 live on ClinicalTrials.gov.