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Clinical Trial
. 2015 May;12(5):872-8.
doi: 10.1016/j.hrthm.2015.01.021. Epub 2015 Jan 17.

Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study

Gaetano M De Ferrari  1 , Lars S Maier  2 , Lluís Mont  3 , Peter J Schwartz  4 , Gregor Simonis  5 , Matthias Leschke  6 , Edoardo Gronda  7 , Giuseppe Boriani  8 , Harald Darius  9 , Laura Guillamón Torán  10 , Irene Savelieva  11 , Veronica Dusi  12 , Niccolò Marchionni  13 , Miguel Quintana Rendón  14 , Kai Schumacher  15 , Giulia Tonini  16 , Lorenzo Melani  17 , Stefano Giannelli  16 , Carlo Alberto Maggi  16 , A John Camm  11 ; RAFFAELLO Investigators (see Online Supplementary Appendix for List of Participating Centers and Investigators)
Collaborators, Affiliations
Clinical Trial

Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study

Gaetano M De Ferrari et al. Heart Rhythm. 2015 May.

Abstract

Background: Currently available antiarrhythmic agents for the treatment of atrial fibrillation (AF) have important limitations, leaving an unmet need for safe and effective therapy. Ranolazine is an approved antianginal agent with a favorable safety profile and electrophysiologic properties suggesting a potential role in the treatment of AF.

Objective: The purpose of this study was to assess the safety and efficacy of ranolazine in the prevention of AF recurrence after successful electrical cardioversion and to ascertain the most appropriate dose of this agent.

Methods: This prospective, multicenter, randomized, double-blind, placebo-control parallel group phase II dose-ranging trial randomized patients with persistent AF (7 days to 6 months) 2 hours after successful electrical cardioversion to placebo, or ranolazine 375 mg, 500 mg, or 750 mg bid. Patients were monitored daily by transtelephonic ECG. The primary end-point was the time to first AF recurrence.

Results: Of 241 patients randomized, 238 took at least 1 drug dose. Ranolazine proved to be safe and tolerable. No dose of the drug significantly prolonged time to AF recurrence. AF recurred in 56.4%, 56.9%, 41.7%, and 39.7% of patients in the placebo, ranolazine 375 mg, ranolazine 500 mg, and ranolazine 750 mg groups, respectively. The reduction in overall AF recurrence in the combined 500-mg and 750-mg groups was of borderline significance compared to the placebo group (P = .053) and significant compared to 375-mg group (P = .035).

Conclusion: No dose of ranolazine significantly prolonged time to AF recurrence. However, the 500-mg and 750 mg-groups combined reduced AF recurrences, suggesting a possible role for this agent in the treatment of AF.

Trial registration: ClinicalTrials.gov NCT01534962.

Keywords: Antiarrhythmic drug; Atrial fibrillation; Atrial flutter; Cardioversion; Electrophysiology; Randomized controlled trial; Ranolazine.

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