Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation

Who is this study for? Patients with Atrial Fibrillation
What treatments are being studied? Dronedarone
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: No
View:

• Age >=21 years

• First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days)

• Acute care encounter for evaluation or treatment of atrial fibrillation, within 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.

Locations
United States
California
Cedars Sinai Medical Center
Recruiting
Los Angeles
UCLA Medical Center - Harbor
Recruiting
Torrance
Illinois
Riverside Medical Center
Recruiting
Kankakee
Methodist Medical Center of Illinois
Recruiting
Peoria
Proctor Community Hospital
Recruiting
Peoria
St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. Francis
Recruiting
Springfield
St. John's Hospital of the Hospital Sisters of the Third Order of St. Francis
Recruiting
Springfield
Carle Foundation Hospital
Recruiting
Urbana
Indiana
Parkview Hospital, Inc.
Recruiting
Fort Wayne
Kentucky
Baptist Health Lexington
Recruiting
Lexington
Saint Joseph Hospital
Recruiting
Lexington
Massachusetts
Brigham and Womens Hospital
Recruiting
Boston
Maryland
Luminis Health Anne Arundel Medical Center
Recruiting
Annapolis
Adventist Healthcare Shady Grove Medical Center
Recruiting
Rockville
Michigan
Sparrow Hospital
Recruiting
Lansing
McLaren Macomb
Recruiting
Mount Clemens
North Carolina
Durham VA Health Care System
Recruiting
Durham
WakeMed Raleigh Campus
Recruiting
Raleigh
New Jersey
Cooper University Hospital
Recruiting
Camden
Ohio
The MetroHealth System
Recruiting
Cleveland
Wooster Community Hospital Health System
Recruiting
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Utah
University of Utah Hospital
Recruiting
Salt Lake City
Wisconsin
Mayo Clinic Hospital - Franciscan Healthcare La Crosse
Recruiting
La Crosse
University Hospital - University of Wisconsin-Madison
Recruiting
Madison
Marshfield Medical Center
Recruiting
Marshfield
Marshfield Medical Center
Recruiting
Weston
Contact Information
Primary
Samantha Johnson, MPH
ChangeAFib@heart.org
+1 (609) 223-3730
Backup
Susana Almeida-Peters, BN, RN
ChangeAF@duke.edu
+1 (919) TBD-0000
Time Frame
Start Date: October 29, 2021
Estimated Completion Date: December 2024
Participants
Target number of participants: 3000
Treatments
Experimental: Dronedarone
In 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.
No Intervention: Usual care
In 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.
Related Therapeutic Areas
Sponsors
Leads: American Heart Association
Collaborators: Duke Clinical Research Institute, Sanofi

This content was sourced from clinicaltrials.gov

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