The Adjunctive Ventricular Arrhythmia Suppression Trial (... | NCT01480336

Studies
The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

NCT01480336

Sponsor

Hartford Hospital

Status

Completed

Last Update Posted

Mar 19, 2013Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Arrhythmia

Interventions

Amiodarone Plus Ranolazine
Amiodarone with Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Nov 23, 2011

First Submission Date that Met QC Criteria

Nov 23, 2011

First Posted Date

Nov 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2013

Last Update Posted Date

Mar 19, 2013Estimated

Name	Class
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amiodarone with Placebo	Placebo Comparator		Drug: Amiodarone with Placebo
Amiodarone with Ranolazine	Active Comparator		Drug: Amiodarone Plus Ranolazine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amiodarone Plus Ranolazine	Drug	Ranolazine 500mg by mouth twice daily	Amiodarone with Ranolazine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Baker, Pharm.D.	University of Connecticut	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hartford Hospital		Hartford	Connecticut	06102	United States

Type	Date	Date Unknown
Release	Dec 11, 2024
Reset	Jan 2, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 11, 2024			Jan 2, 2025

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000638	Amiodarone
D000069458	Ranolazine

Ancestor Terms

ID	Term
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided