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

Cardiovascular Consultants of Nevada

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Atrial Fibrillation; Chronic Stable Angina; Ventricular Tachycardia

Treatments: Drug: placebo; Drug: ranolazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01558830

IN-US-259-0121

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

sugar pill

Placebo Comparator group

Description:

one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy

Treatment:

Drug: placebo

Ranolazine

Active Comparator group

Description:

500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms

Treatment:

Drug: ranolazine