NCT01558830

Safety of Amiodarone and Ranolazine Together in Patients With Angina

Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cardiovascular Consultants of Nevada · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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

• Chronic Stable Angina
• Coronary Artery Disease
• Atrial Fibrillation
• Ventricular Tachycardia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-04-01
• Completion: 2013-07-01
• First posted: 2012-03-20
• Last updated: 2012-03-21

Locations

3 sites across 1 country: United States