CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,012 enrolled
Drug / intervention
Ranolazinedrug
Likely dose
Ranolazine 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01215253
NCT01215253Phase 3Completed
CompareCT.gov

Late Sodium Current Blockade in High-Risk ICD Patients

University of Rochester·interventional·Posted Oct 6, 2010·Updated Aug 27, 2018

In Brief

A Phase 3 clinical trial evaluating Ranolazine for Ischemic Cardiomyopathy and 2 related conditions. Completed, enrolled 1,012 participants across 90 sites in 2 countries.

Detailed Summary

The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is routinely prescribed in enrolled patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2010
Enrollment StartSep 1, 2011
Primary CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.7 years ago

Interventions

Ranolazinedrug

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.