Currently available antiarrhythmic agents for the treatment of atrial fibrillation 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 atrial fibrillation.
The purpose of this study RAFFAELLO ( Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion ) was to assess the safety and efficacy of Ranolazine in the prevention of atrial fibrillation recurrence after successful electrical cardioversion and to ascertain the most appropriate dose of this agent.
This prospective, multicenter, randomized, double-blind, placebo-control parallel group phase II dose-ranging trial randomized patients with persistent atrial fibrillation ( 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 atrial fibrillation recurrence.
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 atrial fibrillation recurrence. Atrial fibrillation 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 atrial fibrillation recurrence in the combined 500-mg and 750-mg groups was of borderline significance compared to the placebo group ( P =0.053 ) and significant compared to 375-mg group ( P =0.035 ).
In conclusion, no dose of Ranolazine significantly prolonged time to atrial fibrillation recurrence. However, the 500-mg and 750 mg-groups combined reduced atrial fibrillation recurrences, suggesting a possible role for this agent in the treatment of atrial fibrillation. ( Xagena )
De Ferrari GM et al, Heart Rhythm 2015;12:872-878