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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Cardiovascular Consultants of Nevada.
Recruitment status was:  Recruiting
Gilead Sciences
Information provided by (Responsible Party):
Cardiovascular Consultants of Nevada Identifier:
First received: March 18, 2012
Last updated: March 20, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Chronic Stable Angina
Coronary Artery Disease
Atrial Fibrillation
Ventricular Tachycardia
Drug: ranolazine
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina

Resource links provided by NLM:

Further study details as provided by Cardiovascular Consultants of Nevada:

Primary Outcome Measures:
  • ventricular arrhythmia [ Time Frame: 3 months ]
    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.

Secondary Outcome Measures:
  • atrial arrhythmia burden [ Time Frame: 3 months ]
    burden of atrial arrhythmias will be measured on serial holter monitor recordings

  • Electrocardiogram (EKG) corrected QT (QTc) interval measurement [ Time Frame: over the 3 month trial ]
    The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion

  • hospitalization [ Time Frame: 3 months ]
    Hospitalization rates, if any, will be serially quantitated to trial completion

  • syncope hospitalization [ Time Frame: 3 months ]
    syncope hospitalization rate quantitation to trial completion

  • liver function assay [ Time Frame: 3 months ]
    serum liver function testing will be conducted at baseline and serially to trial completion

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ranexa


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01558830

Contact: Erik J Sirulnick, MD 702-731-8224
Contact: Christie Abano, RN 702-731-8224

United States, Nevada
Cardiovascular Consultants of Nevada Recruiting
Henderson, Nevada, United States, 89052
Cardiovascular Consultants of Nevada Recruiting
Las Vegas, Nevada, United States, 89144
Cardiovascular Consultants of Nevada Recruiting
Las Vegas, Nevada, United States, 89196
Sponsors and Collaborators
Cardiovascular Consultants of Nevada
Gilead Sciences
Principal Investigator: Erik J SIrulnick, MD Cardiovascular Consultants of Nevada
  More Information

Responsible Party: Cardiovascular Consultants of Nevada Identifier: NCT01558830     History of Changes
Other Study ID Numbers: IN-US-259-0121
Study First Received: March 18, 2012
Last Updated: March 20, 2012

Keywords provided by Cardiovascular Consultants of Nevada:

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 28, 2017