Safety of Amiodarone and Ranolazine Together in Patients With Angina
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Chronic Stable Angina, Coronary Artery Disease, Atrial Fibrillation, Ventricular Tachycardia
In brief
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.
Key facts
- Study ID
- NCT01558830
- Run by
- Cardiovascular Consultants of Nevada
- People needed
- 50
- Starts
- 2012-01-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2012-03-21
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ischemic cardiac disease
- chronic anginal symptoms
- on amiodarone therapy for other cardiac conditions
You may not qualify if…
- pregnant
- non-English speaking
- unstable angina
- baseline electrocardiogram (EKG) corrected QT (QTc)>490ms
- severe thyroid dysfunction
- heart block without a pacer system
- liver disease
Where it is running
- Cardiovascular Consultants of Nevada — Henderson, Nevada, United States (enrolling)
- Cardiovascular Consultants of Nevada — Las Vegas, Nevada, United States (enrolling)
- Cardiovascular Consultants of Nevada — Las Vegas, Nevada, United States (enrolling)
Full record on ClinicalTrials.gov
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