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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01349491
Recruitment Status : Terminated (low recruitement rates)
First Posted : May 6, 2011
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Ranolazine Drug: Matching placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: A Pilot Study
Study Start Date : March 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arms and Interventions
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Arm Intervention/treatment
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.
Other Name: Ranexa
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.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome - Number of Participants With Atrial Fibrillation [ Time Frame: 6 months ]
    To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349491


Locations
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United States, Oklahoma
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Gilead Sciences
Investigators
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Principal Investigator: Udho Thadani, MD University of Oklahoma
Study Director: Stavros Stavrakis, MD University of Oklahoma
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01349491    
Other Study ID Numbers: 2399
First Posted: May 6, 2011    Key Record Dates
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Oklahoma:
Atrial Fibrillation
Ranolazine
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action