Status:
COMPLETED
Patent Foramen Ovale in Cryptogenic Stroke Study
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Ischemic Stroke
Patent Foramen Ovale
Eligibility:
All Genders
30-85 years
Phase:
PHASE4
Brief Summary
The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducte...
Eligibility Criteria
Inclusion
- Age 30-85
- Ischemic stroke within 30 days
- Glasgow outcome scale ≥ 3
- No contraindications to warfarin/aspirin
Exclusion
- Basal INR \> 1.4
- Post-procedural stroke
- Severe carotid atherosclerosis
- Cardioembolic stroke
- Contraindications to transesophageal echocardiography
Key Trial Info
Start Date :
June 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2000
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00697151
Start Date
June 1 1993
End Date
June 1 2000
Last Update
September 15 2011
Active Locations (1)
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1
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032