Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

This study has been completed.

First Received on November 22, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia short QT syndrome

MedlinePlus related topics: Shock

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

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.

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

Additional relevant MeSH terms:

Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Sotalol
Amiodarone
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Enzyme Inhibitors
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012