The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480336
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : March 19, 2013
Gilead Sciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: Amiodarone Plus Ranolazine Drug: Amiodarone with Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pharmacokinetic Parameter Estimates [ Time Frame: 12 hours ]
    Absorption, Peak concentration, time to peak concentration, clearance, area under the curve

Secondary Outcome Measures :
  1. Electrocardiogram (ECG) [ Time Frame: 12 hours ]
    The QT/QTc interval and other ECG parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Hartford Hospital Identifier: NCT01480336     History of Changes
Other Study ID Numbers: KLUG003330HE
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Hartford Hospital:

Additional relevant MeSH terms:
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors