Safety of Amiodarone and Ranolazine Together in Patients With Angina

NCT01558830 | Unknown Phase 4 DMC

• 1 other identifier: IN-US-259-0121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

amiodarone; ranolazine; safety; arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• atrial arrhythmia burden

  3 months

• Electrocardiogram (EKG) corrected QT (QTc) interval measurement

  over the 3 month trial

• hospitalization

  3 months

• syncope hospitalization

  3 months

• liver function assay

  3 months

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

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

Drug: placebo

Ranolazine

ACTIVE COMPARATOR

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

Drug: ranolazine

Interventions

ranolazine DRUG

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

Also known as: Ranexa

Ranolazine

placebo DRUG

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

sugar pill

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ischemic cardiac disease
• chronic anginal symptoms
• on amiodarone therapy for other cardiac conditions

You may not qualify if:

• pregnant
• non-English speaking
• unstable angina
• baseline electrocardiogram (EKG) corrected QT (QTc)\>490ms
• severe thyroid dysfunction
• heart block without a pacer system
• liver disease

Sponsors & Collaborators

• Cardiovascular Consultants of Nevada: lead
• Gilead Sciences: collaborator

Study Sites (3)

Cardiovascular Consultants of Nevada

Henderson, Nevada, 89052, United States

RECRUITING

Cardiovascular Consultants of Nevada

Las Vegas, Nevada, 89144, United States

RECRUITING

Cardiovascular Consultants of Nevada

Las Vegas, Nevada, 89196, United States

RECRUITING

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease; Atrial Fibrillation; Tachycardia, Ventricular; Arrhythmias, Cardiac

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Erik J SIrulnick, MD

  Cardiovascular Consultants of Nevada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik J Sirulnick, MD

CONTACT

702-731-8224; erikmd@me.com

Christie Abano, RN

CONTACT

702-731-8224; cabano@ccnv.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 20, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

US (3)