The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

This study has been completed.
Gilead Sciences
Information provided by (Responsible Party):
Hartford Hospital Identifier:
First received: November 23, 2011
Last updated: March 18, 2013
Last verified: March 2013

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.

Condition Intervention
Drug: Amiodarone Plus Ranolazine
Drug: Amiodarone with Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Pharmacokinetic Parameter Estimates [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Absorption, Peak concentration, time to peak concentration, clearance, area under the curve

Secondary Outcome Measures:
  • Electrocardiogram (ECG) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    The QT/QTc interval and other ECG parameters

Enrollment: 19
Study Start Date: February 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Amiodarone with Placebo Drug: Amiodarone with Placebo
stabel dose of amiodarone as prescribed by cardiologist
Active Comparator: Amiodarone with Ranolazine Drug: Amiodarone Plus Ranolazine
Ranolazine 500mg by mouth twice daily


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01480336

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
Gilead Sciences
Principal Investigator: William Baker, Pharm.D. University of Connecticut
  More Information

No publications provided

Responsible Party: Hartford Hospital Identifier: NCT01480336     History of Changes
Other Study ID Numbers: KLUG003330HE
Study First Received: November 23, 2011
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents processed this record on April 16, 2014