Safety of Amiodarone and Ranolazine Together in Patients With Angina

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Stable Angina Coronary Artery Disease Atrial Fibrillation Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sugar pill

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy

Ranolazine

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

Group Type ACTIVE_COMPARATOR

ranolazine

Intervention Type DRUG

ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina

Interventions

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ranolazine

ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina

Intervention Type DRUG

placebo

one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy

Intervention Type DRUG

Other Intervention Names

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Ranexa

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No