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Completed

NCT Number: NCT01480336

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amiodarone Plus Ranolazine

Drug

Ranolazine 500mg by mouth twice daily

Amiodarone with Placebo

Drug

stabel dose of amiodarone as prescribed by cardiologist

Primary outcomes

  1. Pharmacokinetic Parameter Estimates

    Time frame: 12 hours

    Absorption, Peak concentration, time to peak concentration, clearance, area under the curve

Secondary outcomes

  1. Electrocardiogram (ECG)

    Time frame: 12 hours

    The QT/QTc interval and other ECG parameters

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2011
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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