MedTrace Logo

Safety of Amiodarone and Ranolazine Together in Patients With Angina

NCT01558830 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-03-21

No results posted yet for this study

Summary

Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.

Conditions

Interventions

DRUG

ranolazine

ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina

DRUG

placebo

one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Cardiovascular Consultants of Nevada

    lead OTHER

Principal Investigators

  • Erik J SIrulnick, MD · Cardiovascular Consultants of Nevada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558830 on ClinicalTrials.gov