Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

Atrial Fibrillation Clinical Trial

Official title:

Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01349491
• Other study ID #: Gilead-001
• Status: Recruiting
• Phase: Phase 3
• First received: April 25, 2011
• Last updated: August 8, 2012
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2012
• Source: University of Oklahoma
• Contact: Stavros Stavrakis, MD
• Phone: 405-313-2197
• Email: Stavros-Stavrakis[@]ouhsc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Oklahoma City VA Medical Center	Oklahoma City	Oklahoma
United States	OU Medical Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome - Decreased recurrence of Atrial Fibrillation	To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.	6 months	No
Secondary	Secondary Outcome - Efficacy in preventing hospitalizations for symptomatic Atrial Fibrillation	To evaluate the efficacy of ranolazine in preventing hospitalizations for symptomatic AF. We will follow the patients at 2 weeks, 1, 3 and 6 months after randomization, with an outpatient office visit. At each visit, patients will have a brief history and physical examination, any cardiovascular events, including hospitalizations for symptomatic AF, will be recorded and a 12-lead electrocardiogram will be obtained to assess maintenance of sinus rhythm.	6 months	No