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Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

Primary Purpose

Ventricular Tachycardia

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

amiodarone beta blocker sotalol

About this trial

This is an interventional prevention trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation - Exclusion Criteria: -

Sites / Locations

McMaster University

Outcomes

Primary Outcome Measures

ICD shock for any cause

Secondary Outcome Measures

Full Information

NCT ID

NCT00257959

First Posted

November 22, 2005

Last Updated

July 26, 2006

Sponsor

Connolly, Stuart, M.D.

Collaborators

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00257959

Brief Title

Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Connolly, Stuart, M.D.

Collaborators

Abbott Medical Devices

4. Oversight

5. Study Description

Brief Summary

This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Tachycardia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

amiodarone beta blocker sotalol

Primary Outcome Measure Information:

Title

ICD shock for any cause

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation - Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart Connolly

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster University

City

Hamilton

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

16403928

Citation

Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.

Results Reference

result

PubMed Identifier

16818810

Citation

Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006 Jul 11;114(2):104-9. doi: 10.1161/CIRCULATIONAHA.106.618421. Epub 2006 Jul 3.

Results Reference

result

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Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

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