Safety of Amiodarone and Ranolazine Together in Patients With Angina

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiovascular Consultants of Nevada
• Collaborator: Gilead Sciences
• Treatments: Amiodarone; Ranolazine

Criteria

Inclusion Criteria:

• ischemic cardiac disease

• chronic anginal symptoms

• on amiodarone therapy for other cardiac conditions

Exclusion Criteria:

• pregnant

• non-English speaking

• unstable angina

• baseline electrocardiogram (EKG) corrected QT (QTc)>490ms

• severe thyroid dysfunction

• heart block without a pacer system

• liver disease