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NCT05130268 · ClinicalTrials.gov registry record · Phase 4
Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
A Phase 4 study, sponsored by American Heart Association.
- Completed
- Registry status
- Phase 4
- Development phase
- 339
- Enrollment target
NCT05130268 is a Phase 4 study that has completed, run by American Heart Association. The registered enrollment target is 339 participants.
The verdict
NCT05130268, a Phase 4 study, has completed, sponsored by American Heart Association.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 339 participants
- Enrollment target
Study 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.
Interventions
- DRUG Dronedarone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05130268
The ClinicalTrials.gov registry entry for NCT05130268 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Heart Association, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dronedarone is the first listed.
NCT05130268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05130268 about?
NCT05130268 is a clinical study titled "Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation". 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...
What is the current status of trial NCT05130268?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 339 participants. The study started on 2021-10-29. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT05130268?
The interventions under investigation include: Dronedarone (DRUG).
Who is sponsoring clinical trial NCT05130268?
This trial is sponsored by American Heart Association, which has 9 total clinical trials registered on ClinicalTrials.gov.
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