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

March 16, 2017 updated by: University of Oklahoma

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Udho Thadani, MD, University of Oklahoma
  • Study Director: Stavros Stavrakis, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 25, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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