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.

First Received: November 22, 2005 Last Updated: July 26, 2006 History of Changes

Sponsor:	Connolly, Stuart, M.D.
Collaborator:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

Drug Information available for: Amiodarone hydrochloride Amidox Sotalol hydrochloride Amiodarone Sotalol

U.S. FDA Resources

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:

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

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Tachycardia
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Amiodarone

Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Tachycardia, Ventricular
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009