Atrial Fibrillation, Chronic Stable Angina, Coronary Artery Disease, Ventricular Tachycardia
Conditions
Keywords
amiodarone, ranolazine, safety, arrhythmia
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.
Interventions
DRUGranolazine
ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina
DRUGplacebo
one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy
Sponsors
Gilead Sciences
Cardiovascular Consultants of Nevada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ventricular arrhythmia | 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
| Measure | Time frame | Description |
|---|---|---|
| atrial arrhythmia burden | 3 months | burden of atrial arrhythmias will be measured on serial holter monitor recordings |
| Electrocardiogram (EKG) corrected QT (QTc) interval measurement | over the 3 month trial | The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion |
| hospitalization | 3 months | Hospitalization rates, if any, will be serially quantitated to trial completion |
| syncope hospitalization | 3 months | syncope hospitalization rate quantitation to trial completion |
| liver function assay | 3 months | serum liver function testing will be conducted at baseline and serially to trial completion |
Countries
United States
Contacts
Primary ContactErik J Sirulnick, MD
Backup ContactChristie Abano, RN
Outcome results
None listed