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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina
one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy
Cardiovascular Consultants of Nevada
Henderson, Nevada, United States
RECRUITINGCardiovascular Consultants of Nevada
Las Vegas, Nevada, United States
RECRUITINGCardiovascular Consultants of Nevada
Las Vegas, Nevada, United States
RECRUITINGventricular 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.
Time frame: 3 months
atrial arrhythmia burden
burden of atrial arrhythmias will be measured on serial holter monitor recordings
Time frame: 3 months
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion
Time frame: over the 3 month trial
hospitalization
Hospitalization rates, if any, will be serially quantitated to trial completion
Time frame: 3 months
syncope hospitalization
syncope hospitalization rate quantitation to trial completion
Time frame: 3 months
liver function assay
serum liver function testing will be conducted at baseline and serially to trial completion
Time frame: 3 months
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