ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2

Phase 2 Completed 69 enrolled Milestone Pharmaceuticals Inc. JSS Medical Research Inc. · collab The Montreal Health Innovations Coordinating Center (MHICC) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Many patients with atrial fibrillation (AF) experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study were to demonstrate the superiority of a nasal spray of etripamil over placebo in reducing ventricular rate in patients with AF; and to evaluate the safety and efficacy of etripamil nasal spray in participants with AF.

Timeline

Start: 2020-11-19
Primary completion: 2023-08-03
Completion: 2023-08-10

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Etripamil; p <0.0001; Mean Difference (Final Values) -29.9 (95% CI -40.3 to -19.3); ANCOVA NCT04467905 ↗

registry MEAN Placebo: Nadir (bpm): 130.7 (Standard Deviation 16.4) bpm MEAN Etripamil: Nadir (bpm): 95.2 (Standard Deviation 23.7) bpm NCT04467905 ↗

Publications

Camm AJ, Piccini JP, Alings M, Dorian P, Gosselin G, Guertin MC, Ip JE, Kowey PR, Mondesert B, Prins FJ, Roux JF, Stambler BS, van Eck J, Al Windy N, Thermil N, Shardonofsky S, Bharucha DB, Roy D. Multicenter, Phase 2, Randomized Controlled Study of the Efficacy and Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid Ventricular Rate in Patients With Symptomatic Atrial Fibrillation (ReVeRA-201). Circ Arrhythm Electrophysiol. 2023 Dec;16(12):639-650. doi: 10.1161/CIRCEP.123.012567. Epub 2023 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etripamil	Small molecule	70 mg	Intranasal