NCT01534962

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Dose-ranging Phase II Study Assessing Ranolazine in the Maintenance of Sinus Rhythm After Electrical Cardioversion in Patients With Non-permanent Atrial Fibrillation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Ranolazine	Oral administration, BID; for a maximum of 112 days.
DRUG	Ranolazine	Oral administration, BID; for a maximum of 112 days.
DRUG	Ranolazine	Oral administration, BID; for a maximum of 112 days.
DRUG	Placebo	Oral administration, BID; for a maximum of 112 days.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-10-01
• Completion: 2014-03-01
• First posted: 2012-02-17
• Last updated: 2014-08-19
• Results posted: 2014-08-19

Locations

4 sites across 4 countries: Germany, Italy, Spain, United Kingdom