Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion (GILEAD)

University of Oklahoma (OU)

Status and phase

Terminated

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: Matching placebo

Drug: Ranolazine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01349491

2399

Details and patient eligibility

About

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.

Full description

Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.

Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.

The investigators hypothesize that ranolazine would decrease the incidence of recurrence of 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. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.

Enrollment

10 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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