Dronedarone for Atrial Fibrillation
(CHANGE-AFIB Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJonathan P Piccini, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: American Heart Association

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for adults over 21 with newly diagnosed atrial fibrillation (AF) within the last 120 days, who have been hospitalized for AF evaluation or treatment. Participants must be expected to live at least another year and give informed consent. Excluded are those with severe heart rate or rhythm issues, significant liver impairment, pregnant or breastfeeding women, patients on certain heart treatments, and those ineligible for blood-thinning medication.

Inclusion Criteria

I can sign the consent form and follow the study rules.

I am 21 years old or older.

I can sign the consent form and follow the study's requirements.

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Exclusion Criteria

I have severe heart failure or was hospitalized for it in the last month.

I cannot take blood thinners orally, unless my stroke risk score is low.

I have had or will have treatment to control heart rhythm.

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Treatment Details

Interventions

Dronedarone (Antiarrhythmic drug)

Trial OverviewThe study tests if early use of Dronedarone (400 mg twice daily), in addition to usual care like beta-blockers and stroke prevention therapy based on CHA2DS2-VASc score, can prevent cardiovascular hospitalization or death compared to usual care alone in patients with first-detected AF. The trial will follow participants for a year with two check-ups.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: DronedaroneExperimental Treatment1 Intervention

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.

Group II: Usual careActive Control1 Intervention

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.