Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01349491
First received: April 25, 2011
Last updated: August 8, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Primary Outcome - Decreased recurrence of Atrial Fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.


Secondary Outcome Measures:
  • Secondary Outcome - Efficacy in preventing hospitalizations for symptomatic Atrial Fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 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.
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349491

Contacts
Contact: Stavros Stavrakis, MD 405-313-2197 Stavros-Stavrakis@ouhsc.edu

Locations
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   
Sponsors and Collaborators
University of Oklahoma
Gilead Sciences
Investigators
Principal Investigator: Udho Thadani, MD University of Oklahoma
Study Director: Stavros Stavrakis, MD University of Oklahoma
  More Information

No publications provided

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: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Atrial Fibrillation
Ranolazine

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014