Dronedarone vs class Ic agents for early AF: Protocol for the DRIVE-AF randomized clinical trial
Abstract
Background Early rhythm control is crucial in atrial fibrillation (AF), yet clinical equipoise remains regarding the optimal initial antiarrhythmic drug (AAD). Although class Ic agents are widely used, their safety profile often necessitates complex coadministration with rate-control drugs, potentially limiting adherence. Dronedarone offers distinct safety advantages, but direct randomized comparisons with class Ic agents in early AF are lacking. Objective This study aimed to test the hypothesis that dronedarone is noninferior to class Ic AADs regarding efficacy (AF recurrence) and superior regarding safety (drug discontinuation owing to adverse events). Methods The Dronedarone Rhythm Intervention for Early Atrial Fibrillation trial is a prospective, multicenter, randomized, open-label trial to be conducted at 14 academic centers in Korea. The study will enroll 1898 patients diagnosed as having AF within 12 months who require AAD therapy. Participants will be randomized (1:1) to receive either dronedarone (400 mg twice daily) or standard-of-care class Ic agents (flecainide or propafenone) for 12 months. Results The dual primary endpoints are AF recurrence at 12 months (noninferiority) and drug discontinuation owing to adverse events (superiority). Secondary outcomes include AF-specific quality of life, medication adherence (proportion of days covered), and major adverse cardiovascular events. Analyses will be performed on both intention-to-treat and per-protocol bases.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,898 participants or records.
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