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

176131-M

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.

2021-10-29

2024-06-01

2024-12-01

Active (not recruiting)

Early phase I

3000

Inclusion Criteria: 1. Age \>=21 years. 2. First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days). 3. Electrocardiographic documentation of atrial fibrillation. 4. Estimated life expectancy of at least 1 year. 5. 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. Exclusion Criteria: 1. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (\>7 days) antiarrhythmic drug therapy. 3. 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. 5. 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. 8. 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. 10. Corrected QT interval \>=500 msec. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, prospective, randomized, open-label, pragmatic clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3000, 'type': 'ESTIMATED'}}

2023-11-30