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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558830
Recruitment Status : Unknown
Verified March 2012 by Cardiovascular Consultants of Nevada.
Recruitment status was:  Recruiting
First Posted : March 20, 2012
Last Update Posted : March 21, 2012
Gilead Sciences
Information provided by (Responsible Party):
Cardiovascular Consultants of Nevada

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina
Study Start Date : January 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : July 2013

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 Name: Ranexa

Primary Outcome Measures :
  1. 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 :
  1. atrial arrhythmia burden [ Time Frame: 3 months ]
    burden of atrial arrhythmias will be measured on serial holter monitor recordings

  2. 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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01558830

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

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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
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Principal Investigator: Erik J SIrulnick, MD Cardiovascular Consultants of Nevada

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Responsible Party: Cardiovascular Consultants of Nevada Identifier: NCT01558830     History of Changes
Other Study ID Numbers: IN-US-259-0121
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012
Keywords provided by Cardiovascular Consultants of Nevada:
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Angina Pectoris
Angina, Stable
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Cardiac Conduction System Disease
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