Safety of Amiodarone and Ranolazine Together in Patients With Angina (SARA)

Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Atrial Fibrillation; Ventricular Tachycardia; Chronic Stable Angina
• Intervention / Treatment: Drug: placebo; Drug: ranolazine

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Erik J Sirulnick, MD; Phone Number: 702-731-8224; Email: erikmd@me.com
• Study Contact Backup: Name: Christie Abano, RN; Phone Number: 702-731-8224; Email: cabano@ccnv.com

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Recruiting
      • Cardiovascular Consultants of Nevada
    • Las Vegas, Nevada, United States, 89144
      • Recruiting
      • Cardiovascular Consultants of Nevada
    • Las Vegas, Nevada, United States, 89196
      • Recruiting
      • Cardiovascular Consultants of Nevada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sugar pill; one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy	Drug: placebo; one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy
Active Comparator: Ranolazine; 500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms	Drug: ranolazine; ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina; Other Names: Ranexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
atrial arrhythmia burden	burden of atrial arrhythmias will be measured on serial holter monitor recordings	3 months
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
hospitalization	Hospitalization rates, if any, will be serially quantitated to trial completion	3 months
syncope hospitalization	syncope hospitalization rate quantitation to trial completion	3 months
liver function assay	serum liver function testing will be conducted at baseline and serially to trial completion	3 months

Collaborators and Investigators

• Sponsor: Cardiovascular Consultants of Nevada
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Erik J SIrulnick, MD, Cardiovascular Consultants of Nevada

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: March 18, 2012
• First Submitted That Met QC Criteria: March 18, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 21, 2012
• Last Update Submitted That Met QC Criteria: March 20, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: safety; arrhythmia; amiodarone; ranolazine
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Arrhythmias, Cardiac; Coronary Disease; Cardiac Conduction System Disease; Chest Pain; Coronary Artery Disease; Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Angina Pectoris; Angina, Stable; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: IN-US-259-0121