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| Sponsor: | University of Oklahoma |
|---|---|
| Collaborator: |
Gilead Sciences |
| Information provided by (Responsible Party): | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01349491 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Ranolazine Drug: Matching placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: a Pilot Study |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ranolazine
Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
|
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.
|
|
Placebo Comparator: Placebo
Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
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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.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stavros Stavrakis, MD | 405-313-2197 | Stavros-Stavrakis@ouhsc.edu |
| United States, Oklahoma | |
| Oklahoma City VA Medical Center | Not yet recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Stavros Stavrakis, MD 405-313-2197 Stavros-Stavrakis@ouhsc.edu | |
| OU Medical Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Stavros Stavrakis, MD 405-313-2197 Stavros-Stavrakis@ouhsc.edu | |
| Principal Investigator: | Udho Thadani, MD | University of Oklahoma |
| Study Director: | Stavros Stavrakis, MD | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01349491 History of Changes |
| Other Study ID Numbers: | Gilead-001 |
| Study First Received: | April 25, 2011 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Atrial Fibrillation Ranolazine |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Ranolazine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |