Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation Ranolazine Arrhythmias, Cardiac Antiarrhythmic Agents Cardiac Electroversion Ranexa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
Healthy volunteers: no

Brief summary:
Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib).

After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility.

Maximum treatment duration is 112 days (16 weeks).

Detailed description:
Patients with persistent AFib are screened for eligibility and undergo direct current cardioversion (DCC). If DCC is successful (defined as persistence of sinus rhythm 2 h post-DCC) patients meeting all the inclusion criteria and none of the exclusion criteria are randomly assigned to the treatment arms (Ranolazine low, intermediate, high dose or placebo, given BID).

Transtelephonic ECG devices (TT-ECG) are used for recording of AFib recurrence to be read by a Central ECG Core Laboratory. Any symptoms indicative of AFib have to be recorded by the patient in a diary.

Study Visits are held for screening (Visit 1), at DCC and randomisation (Visit 2), one week post DCC (Visit 3), after 8 weeks of treatment (Visit 4), and at end of treatment (Visit 5). A safety follow-up telephone call is held 2 weeks after end of treatment.

12-Lead ECGs are performed at every visit.

Safety evaluations include regular safety laboratory blood and urine tests, 12-lead ECGs and the continuous recording of adverse events.

A double-dummy technique is used to ensure double-blind conditions.

Arms:
arm 1: Ranolazine, low dose, oral, BID arm 2: Ranolazine, intermediate dose, oral, BID arm 3: Ranolazine, high dose, oral, BID arm 4: Placebo (sugar pill), oral, BID.

Interventions: intervention 1: Ranolazine intervention 2: Ranolazine intervention 3: Ranolazine intervention 4: Placebo
Intervention descriptions: intervention 1: Oral administration, BID; for a maximum of 112 days. intervention 2: Oral administration, BID; for a maximum of 112 days. intervention 3: Oral administration, BID; for a maximum of 112 days. intervention 4: Oral administration, BID; for a maximum of 112 days.

Protocol document: