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Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257959
First Posted: November 24, 2005
Last Update Posted: July 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Jude Medical
Information provided by:
Connolly, Stuart, M.D.
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00257959     History of Changes
Other Study ID Numbers: 1
First Submitted: November 22, 2005
First Posted: November 24, 2005
Last Update Posted: July 27, 2006
Last Verified: November 2005

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
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents


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