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

This study is currently recruiting participants.
Verified March 2012 by Cardiovascular Consultants of Nevada
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Cardiovascular Consultants of Nevada
ClinicalTrials.gov Identifier:
NCT01558830
First received: March 18, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Consultants of Nevada:

Primary Outcome Measures:
  • ventricular arrhythmia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion

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

  • syncope hospitalization [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    syncope hospitalization rate quantitation to trial completion

  • liver function assay [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558830

Contacts
Contact: Erik J Sirulnick, MD 702-731-8224 erikmd@me.com
Contact: Christie Abano, RN 702-731-8224 cabano@ccnv.com

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

No publications provided

Responsible Party: Cardiovascular Consultants of Nevada
ClinicalTrials.gov Identifier: NCT01558830     History of Changes
Other Study ID Numbers: IN-US-259-0121
Study First Received: March 18, 2012
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cardiovascular Consultants of Nevada:
amiodarone
ranolazine
safety
arrhythmia

Additional relevant MeSH terms:
Angina Pectoris
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
 Arrhythmias, Cardiac
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Amiodarone
Ranolazine
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013