The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

Hartford Hospital

Status: Completed

Conditions: Arrhythmia

Treatments: Drug: Amiodarone with Placebo; Drug: Amiodarone Plus Ranolazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01480336

KLUG003330HE

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

19 participants in 2 patient groups, including a placebo group

Amiodarone with Placebo

Placebo Comparator group

Treatment:

Drug: Amiodarone with Placebo

Amiodarone with Ranolazine

Active Comparator group

Treatment:

Drug: Amiodarone Plus Ranolazine