Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC) - Full Text View

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Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

This study has been completed.

Sponsors and Collaborators:	Connolly, Stuart, M.D. St. Jude Medical
Information provided by:	Connolly, Stuart, M.D.
ClinicalTrials.gov Identifier:	NCT00257959

Purpose

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

Condition	Intervention	Phase
Ventricular Tachycardia	Drug: amiodarone beta blocker sotalol	Phase IV

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

Drug Information available for:

Sotalol Sotalol hydrochloride Amiodarone Amidox Amiodarone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Connolly, Stuart, M.D.:

Primary Outcome Measures:

ICD shock for any cause

Estimated Enrollment:	400
Study Start Date:	January 2001
Estimated Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257959

Locations


Canada, Ontario
	McMaster University
	Hamilton, Ontario, Canada

Sponsors and Collaborators

Connolly, Stuart, M.D.

St. Jude Medical

Investigators


Principal Investigator:	Stuart Connolly	McMaster University

Principal Investigator:	Stuart Connolly	McMaster University

More Information

Publications of Results:

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.

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. Epub 2006 Jul 3.

Study ID Numbers:	1
First Received:	November 22, 2005
Last Updated:	July 26, 2006
ClinicalTrials.gov Identifier:	NCT00257959
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Heart Diseases

Tachycardia

Tachycardia, Ventricular

Amiodarone

Sotalol

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Vasodilator Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Anti-Arrhythmia Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008