Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

This study has been completed.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by:
Connolly, Stuart, M.D.
ClinicalTrials.gov Identifier:
NCT00257959
First received: November 22, 2005
Last updated: July 26, 2006
Last verified: November 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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:
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 April 15, 2014