Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

This study has been completed.
St. Jude Medical
Information provided by:
Connolly, Stuart, M.D. Identifier:
First received: November 22, 2005
Last updated: July 26, 2006
Last verified: November 2005
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00257959

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
Connolly, Stuart, M.D.
St. Jude Medical
Principal Investigator: Stuart Connolly McMaster University
  More Information

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

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
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
Autonomic Agents
Peripheral Nervous System Agents processed this record on October 21, 2016