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NCT00257959 Clinical Trial

Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

Ventricular Tachycardia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00257959
Other study ID # 1
Secondary ID
Status Completed
Phase Phase 4
First received November 22, 2005
Last updated July 26, 2006
Start date January 2001
Est. completion date October 2004

Study information
Verified date November 2005
Source Connolly, Stuart, M.D.
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• amiodarone beta blocker sotalol

Locations
Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (2)
Lead Sponsor Collaborator
Connolly, Stuart, M.D. St. Jude Medical

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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, — View Citation

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. Cir — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary ICD shock for any cause
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