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|Summary of Trial: |
The purpose of this study is to determine whether Ranolazine will decrease the likelihood of a composite arrhythmia endpoint consisting of ventricular tachycardia or ventricular fibrillation (VT/VF) requiring ATP therapy, ICD shocks, or death. This trial a randomized, double-blind placebo-controlled trial , enrolling 1,440 high-risk ICD patients who will be treated with Ranolazine or placebo in addition to optimal medical therapy to test the hypothesis that late sodium current blockade contributes to significant reduction in the risk of arrhythmic events or death in high-risk ICD/CRT-D patients.
The study population will consist of patients with ischemic or nonischemic cardiomyopathy who receive their ICDs as standard of care for primary or secondary prevention of mortality following approved indications for ICD therapy. There are limited treatment options for patients at high risk of ventricular arrhythmic events. Ranolazine is a drug with anti-ischemic and antiarrhythmic properties that uniquely blocks late sodium current, decreases intracellular calcium overload, and improves diastolic relaxation of the ventricles. The antiischemic and antiarrhythmic properties of Ranolazine might decrease the likelihood of arrhythmic events and improve the clinical course of patients with ventricular arrhythmias.
Since the study will enroll and subsequently randomize patients who are routinely implanted with ICD devices, exclusion criteria will be limited mostly to conditions precluding or limiting implantation of devices based on currently approved indications. We will exclude patients, who at the time of consent require therapy with amiodarone, sotalol or other antiarrhythmic drug. In cases of prior long-term use of these therapies, a period of a 3-month washout will be required for patients on amiodarone and a 1-week washout in patients on sotalol or other short-acting antiarrhythmic drug. For patients who have received short-term (up to 1 week) amiodarone therapy, there must be a 1 week wash-out period, prior to randomization to study drug.
|Principal Investigator:||Dr. Ronald Berger|
Kathy Avara, Research Coordinator
|Study Long Title:|
Ranolazine ICD Trial
|Study Short Title:||RAID|
|JHU IRB Number:|
|Funding Source:||National Institute of Health|
|Sponsor:||University of Rochester|
|Clinical Trial Site:|
Johns Hopkins Hospital
|Anticipated End Date:||2009|
|Compensation for Participating:||None|