Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
630 participants
INTERVENTIONAL
1993-06-30
2000-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Warfarin
Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
Warfarin
Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
Aspirin
Aspirin 325 mg plus placebo warfarin
Aspirin
Aspirin 325 mg once a day; placebo warfarin once a day
Interventions
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Warfarin
Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
Aspirin
Aspirin 325 mg once a day; placebo warfarin once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ischemic stroke within 30 days
* Glasgow outcome scale ≥ 3
* No contraindications to warfarin/aspirin
Exclusion Criteria
* Post-procedural stroke
* Severe carotid atherosclerosis
* Cardioembolic stroke
* Contraindications to transesophageal echocardiography
30 Years
85 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Columbia University
OTHER
Responsible Party
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Columbia University
Principal Investigators
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Shunichi Homma, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia College of Physicians and Surgeons
New York, New York, United States
Countries
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References
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Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP; PFO in Cryptogenic Stroke Study (PICSS) Investigators. Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study. Circulation. 2002 Jun 4;105(22):2625-31. doi: 10.1161/01.cir.0000017498.88393.44.
Homma S, DiTullio MR, Sacco RL, Sciacca RR, Mohr JP; PICSS Investigators. Age as a determinant of adverse events in medically treated cryptogenic stroke patients with patent foramen ovale. Stroke. 2004 Sep;35(9):2145-9. doi: 10.1161/01.STR.0000135773.24116.18. Epub 2004 Jul 1.
Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP. Atrial anatomy in non-cardioembolic stroke patients: effect of medical therapy. J Am Coll Cardiol. 2003 Sep 17;42(6):1066-72. doi: 10.1016/s0735-1097(03)00907-0.
Di Tullio MR, Russo C, Jin Z, Sacco RL, Mohr JP, Homma S; Patent Foramen Ovale in Cryptogenic Stroke Study Investigators. Aortic arch plaques and risk of recurrent stroke and death. Circulation. 2009 May 5;119(17):2376-82. doi: 10.1161/CIRCULATIONAHA.108.811935. Epub 2009 Apr 20.
Other Identifiers
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6372
Identifier Type: -
Identifier Source: org_study_id
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