The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

Arrhythmia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480336
• Other study ID #: KLUG003330HE
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: March 18, 2013
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Drug:
• Amiodarone Plus Ranolazine
Ranolazine 500mg by mouth twice daily
• Amiodarone with Placebo
stabel dose of amiodarone as prescribed by cardiologist

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameter Estimates	Absorption, Peak concentration, time to peak concentration, clearance, area under the curve	12 hours	No
Secondary	Electrocardiogram (ECG)	The QT/QTc interval and other ECG parameters	12 hours	No