The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

NCT ID: NCT01480336

Last Updated: 2013-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amiodarone with Placebo

Group Type PLACEBO_COMPARATOR

Amiodarone with Placebo

Intervention Type DRUG

stabel dose of amiodarone as prescribed by cardiologist

Amiodarone with Ranolazine

Group Type ACTIVE_COMPARATOR

Amiodarone Plus Ranolazine

Intervention Type DRUG

Ranolazine 500mg by mouth twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amiodarone Plus Ranolazine

Ranolazine 500mg by mouth twice daily

Intervention Type DRUG

Amiodarone with Placebo

stabel dose of amiodarone as prescribed by cardiologist

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Baker, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KLUG003330HE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ranolazine in Ischemic Cardiomyopathy
NCT01345188 COMPLETED PHASE4