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

Primary Purpose

Chronic Stable Angina, Coronary Artery Disease, Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ranolazine
placebo
Sponsored by
Cardiovascular Consultants of Nevada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina focused on measuring amiodarone, ranolazine, safety, arrhythmia

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Consultants of NevadaRecruiting
  • Cardiovascular Consultants of NevadaRecruiting
  • Cardiovascular Consultants of NevadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

sugar pill

Ranolazine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

atrial arrhythmia burden
burden of atrial arrhythmias will be measured on serial holter monitor recordings
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion
hospitalization
Hospitalization rates, if any, will be serially quantitated to trial completion
syncope hospitalization
syncope hospitalization rate quantitation to trial completion
liver function assay
serum liver function testing will be conducted at baseline and serially to trial completion

Full Information

First Posted
March 18, 2012
Last Updated
March 20, 2012
Sponsor
Cardiovascular Consultants of Nevada
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01558830
Brief Title
Safety of Amiodarone and Ranolazine Together in Patients With Angina
Acronym
SARA
Official Title
Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiovascular Consultants of Nevada
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina, Coronary Artery Disease, Atrial Fibrillation, Ventricular Tachycardia
Keywords
amiodarone, ranolazine, safety, arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy
Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms
Intervention Type
Drug
Intervention Name(s)
ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy
Primary Outcome Measure Information:
Title
ventricular arrhythmia
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
atrial arrhythmia burden
Description
burden of atrial arrhythmias will be measured on serial holter monitor recordings
Time Frame
3 months
Title
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
Description
The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion
Time Frame
over the 3 month trial
Title
hospitalization
Description
Hospitalization rates, if any, will be serially quantitated to trial completion
Time Frame
3 months
Title
syncope hospitalization
Description
syncope hospitalization rate quantitation to trial completion
Time Frame
3 months
Title
liver function assay
Description
serum liver function testing will be conducted at baseline and serially to trial completion
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erik J Sirulnick, MD
Phone
702-731-8224
Email
erikmd@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christie Abano, RN
Phone
702-731-8224
Email
cabano@ccnv.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik J SIrulnick, MD
Organizational Affiliation
Cardiovascular Consultants of Nevada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Consultants of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiovascular Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiovascular Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89196
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Safety of Amiodarone and Ranolazine Together in Patients With Angina

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