Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

NCT ID: NCT01349491

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-06-30

Brief 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.

Detailed 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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranolazine

Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.

Placebo

Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.

Group Type: PLACEBO_COMPARATOR

Matching placebo

Intervention Type: DRUG

Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.

Interventions

Ranolazine

Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.

Intervention Type: DRUG

Matching placebo

Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.

Intervention Type: DRUG

Other Intervention Names

Ranexa; Placebo

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Udho Thadani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Stavros Stavrakis, MD

Role: STUDY_DIRECTOR

University of Oklahoma

Locations

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, United States

OU Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

2399

Identifier Type: -

Identifier Source: org_study_id