Trial | NCT01558830  Report issue

Title

Safety of Amiodarone and Ranolazine Together in Patients With Angina
Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranolazine ...

  • Study Participants

    50
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.
Study Started
Jan 31
2012
Primary Completion
Apr 30
2013
Anticipated
Study Completion
Jul 31
2013
Anticipated
Last Update
Mar 21
2012
Estimate

Drug ranolazine

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

  • Other names: Ranexa

Drug placebo

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

sugar pill Placebo Comparator

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

Ranolazine Active Comparator

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

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
No Results Posted