Recruiting

Amiodarone & Ranolazine

Sponsor:

Cardiovascular Consultants of Nevada

Code:

NCT01558830

Conditions

Chronic Stable Angina

Coronary Artery Disease

Atrial Fibrillation

Ventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

ranolazine

placebo

Study Details

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.

Conditions

Chronic Stable Angina

Coronary Artery Disease

Atrial Fibrillation

Ventricular Tachycardia

Study ID

NCT01558830

Start date

Jan, 2012

Status verified date

Mar, 2012

Completion date

Jul, 2013

Anticipated

Primary completion date

Apr, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: sugar pill

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

active comparator: Ranolazine

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

Interventions

ranolazine

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

placebo

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

Primary outcome measure

  • ventricular arrhythmia [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Erik J Sirulnick, MD

702-731-8224erikmd@me.com

Locations

Cardiovascular Consultants of Nevada

Recruiting

Henderson, Nevada, United States, 89052

Cardiovascular Consultants of Nevada

Recruiting

Las Vegas, Nevada, United States, 89144

Cardiovascular Consultants of Nevada

Recruiting

Las Vegas, Nevada, United States, 89196

More Information

Sponsor

Cardiovascular Consultants of Nevada

Last update posted

Mar 21, 2012

Last verified

Mar, 2012

Keywords

  • amiodarone
  • ranolazine
  • safety
  • arrhythmia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiovascular Consultants of Nevada on 2012-03-21.