Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery

Phase 3 Completed 190 enrolled Astellas Pharma Inc Advanz Pharma · collab Astellas Pharma US, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

Timeline

Start: 2004-06
Primary completion: 2007-02
Completion: 2007-02

Outcome

Met primary endpoint

paper In patients with AF, 47 of 100 (47%) who received vernakalant converted to SR compared with 7 of 50 (14%) patients who received placebo (P<0.001). PMID 19948506 ↗

Publications

Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vernakalant	Other / unclassified	3 mg/kg	Intravenous