Safety of Amiodarone and Ranolazine Together in Patients With Angina

Phase 4

• Conditions: Chronic Stable Angina; Coronary Artery Disease; Ventricular Tachycardia; Atrial Fibrillation
• Interventions: Drug: placebo; Drug: ranolazine

• Registration Number: NCT01558830
• Lead Sponsor: Cardiovascular Consultants of Nevada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-18
• Study First Submitted QC: 2012-03-18
• Study First Posted: 2012-03-20
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21
• Primary Completion: 2013-04
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	placebo	one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy
Ranolazine	ranolazine	500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms

Primary Outcome Measures

Name	Time	Method
ventricular arrhythmia	3 months	primary outcome is the burden of ventricular arrhythmias measured on serial holter monitor recordings, stress test recordings, pacemaker or implantable defibrillator (ICD) recordings if available, at baseline and serially to trial completion.

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram (EKG) corrected QT (QTc) interval measurement	over the 3 month trial	The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion
liver function assay	3 months	serum liver function testing will be conducted at baseline and serially to trial completion
syncope hospitalization	3 months	syncope hospitalization rate quantitation to trial completion
atrial arrhythmia burden	3 months	burden of atrial arrhythmias will be measured on serial holter monitor recordings
hospitalization	3 months	Hospitalization rates, if any, will be serially quantitated to trial completion

Trial Locations

Locations (1)

Cardiovascular Consultants of Nevada; 🇺🇸 Las Vegas, Nevada, United States