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Clinical trialNCT05130268CompletedPhase 4Interventional

Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation

SponsorAmerican Heart AssociationEnrollment339Atrial Fibrillation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

103 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Thomas Hospital

    Fairhope, Alabama, United States

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, United States

  • Honorhealth Scottsdale Shea Medical Center

    Scottsdale, Arizona, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, United States

  • Los Angeles Medical Center (kaiser Permenente)

    Los Angeles, California, United States

  • West Los Angeles Medical Center

    Los Angeles, California, United States

  • Uc Irvine Medical Center (aka Uci Health)

    Orange, California, United States

  • Los Robles Health System - Los Robles Regional Medical Center

    Thousand Oaks, California, United States

  • Ucla Medical Center - Harbor

    Torrance, California, United States

  • Colorado Heart & Vascular Group - St. Anthony'S Hospital

    Lakewood, Colorado, United States

  • Colorado Heart & Vascular Group - St. Anthony'S North Health Campus

    Westminster, Colorado, United States

  • Christiana Hospital

    Newark, Delaware, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, United States

  • Enmanuel Advanced Research Center, Llc

    Miami, Florida, United States

  • Excellence Medical and Research, Llc

    Miami, Florida, United States

  • Golden Touch Clinical Research

    Miami, Florida, United States

  • Life Spring Research Foundation, Llc

    Miami, Florida, United States

  • Nouvelle Clinical Research Llc

    Miami, Florida, United States

  • the Miami Research Group

    Miami, Florida, United States

  • Ocean Wellness Center, Llc

    Miami Gardens, Florida, United States

  • Pharma Medical Innovations

    Miami Lakes, Florida, United States

  • the Angel Medical Research

    Miami Lakes, Florida, United States

  • Northside Hospital

    St. Petersburg, Florida, United States

  • Guardian Angel Research Center

    Tampa, Florida, United States

  • Northeast Georgia Medical Center

    Gainesville, Georgia, United States

  • Georgia Arrhythmia Consultants and Research Institute

    Macon, Georgia, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, United States

  • Mt Sinai Hospital Medical Center

    Chicago, Illinois, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • University of Illinois Hospital

    Chicago, Illinois, United States

  • Riverside Medical Center

    Kankakee, Illinois, United States

  • Loyola University Medical Center

    Maywood, Illinois, United States

  • Captain James A Lovell Federal Health Care Center

    North Chicago, Illinois, United States

  • Methodist Medical Center of Illinois

    Peoria, Illinois, United States

  • Proctor Community Hospital

    Peoria, Illinois, United States

  • Trinity Rock Island

    Rock Island, Illinois, United States

  • St. Elizabeth'S Hospital of the Hospital Sisters of the Third Order of St. Francis

    Springfield, Illinois, United States

  • St. John'S Hospital of the Hospital Sisters of the Third Order of St. Francis

    Springfield, Illinois, United States

  • Carle Foundation Hospital

    Urbana, Illinois, United States

  • Parkview Hospital, Inc.

    Fort Wayne, Indiana, United States

63 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Oct 2021
Primary completion
31 Jan 2024
Completion
30 Jun 2024
Last update posted
28 Jan 2025
Registered enrollment
339
Registry id
NCT05130268

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.