The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

March 18, 2013 updated by: Hartford Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameter Estimates
Time Frame: 12 hours
Absorption, Peak concentration, time to peak concentration, clearance, area under the curve
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiogram (ECG)
Time Frame: 12 hours
The QT/QTc interval and other ECG parameters
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: William Baker, Pharm.D., University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (ESTIMATE)

November 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLUG003330HE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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