Safety of Amiodarone and Ranolazine Together in Patients With Angina

Coronary Artery Disease Clinical Trial

— SARA  

Official title:

Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01558830
• Other study ID #: IN-US-259-0121
• Status: Unknown status
• Phase: Phase 4
• First received: March 18, 2012
• Last updated: March 20, 2012
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2012
• Source: Cardiovascular Consultants of Nevada
• Contact: Erik J Sirulnick, MD
• Phone: 702-731-8224
• Email: erikmd[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Atrial Fibrillation
• Chronic Stable Angina
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Drug:
• ranolazine
ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina
• placebo
one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy

Locations

Country	Name	City	State
United States	Cardiovascular Consultants of Nevada	Henderson	Nevada
United States	Cardiovascular Consultants of Nevada	Las Vegas	Nevada
United States	Cardiovascular Consultants of Nevada	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Consultants of Nevada	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

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