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The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01480336
First received: November 23, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Arrhythmia
 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:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480336

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

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov 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:
Arrhythmia

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Ranolazine
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013