The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
Not Applicable
Completed
- Conditions
- Arrhythmia
- Interventions
- Registration Number
- NCT01480336
- Lead Sponsor
- Hartford Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amiodarone with Placebo Amiodarone with Placebo - Amiodarone with Ranolazine Amiodarone Plus Ranolazine -
- Primary Outcome Measures
Name Time Method Pharmacokinetic Parameter Estimates 12 hours Absorption, Peak concentration, time to peak concentration, clearance, area under the curve
- Secondary Outcome Measures
Name Time Method Electrocardiogram (ECG) 12 hours The QT/QTc interval and other ECG parameters
Trial Locations
- Locations (1)
Hartford Hospital
🇺🇸Hartford, Connecticut, United States