The Pharmacokinetics and Electrocardiographic Implications of Adjunctive Amiodarone and Ranolazine Therapy in Patients on Implantable Cardioverter Defibrillators: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

Hartford Hospital1 site in 1 country19 target enrollmentFebruary 2011

ConditionsArrhythmia

InterventionsAmiodarone with Placebo Amiodarone Plus Ranolazine

DrugsAmiodarone Plus Ranolazine Amiodarone with Placebo

Overview

Phase: Not Applicable
Intervention: Amiodarone with Placebo
Conditions: Arrhythmia
Sponsor: Hartford Hospital
Enrollment: 19
Locations: 1
Primary Endpoint: Pharmacokinetic Parameter Estimates
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

January 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hartford Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with an ICD who were on a stable dose of amiodarone for the past 60 days

Exclusion Criteria

•Patients with a life expectancy of less than 6 months
•Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis.
•Pregnancy or lactation.
•Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir
•Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.