Overview

Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

Status:
Terminated
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oklahoma
Collaborator:
Gilead Sciences
Treatments:
Ranolazine
Criteria
Inclusion Criteria:

- Male or female with persistent atrial fibrillation, aged 21 or older

- Duration of atrial fibrillation less than one year

- The patient does not have any contraindications for anticoagulation

- The patient is willing to participate in the study for a total of 6 months with 3
outpatient office visits

- The patient has provided written informed consent during the screening visit to any
test or procedure being performed, or medication being changed, for this study.

- The patient has no clinically significant abnormal clinical laboratory values, which
in the investigator's opinion precludes the patient from safely participating in the
study.

Exclusion Criteria:

- Any contraindication for anticoagulation

- New York Heart Association class IV heart failure

- Currently taking anti-arrhythmic drugs

- Chronic kidney disease (serum creatinine less than 2.5mg/dL) or severe liver
dysfunction

- Pregnancy/nursing

- Prolonged QT interval (>500ms)

- Taking other medications known to prolong the QT interval

- Taking other medications known to affect the metabolism of ranolazine