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Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697151
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : September 15, 2011
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Columbia University

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 conducted at 48 U.S. Institutions.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Patent Foramen Ovale Drug: Warfarin Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Patent Foramen Ovale in Cryptogenic Stroke Study
Study Start Date : June 1993
Actual Primary Completion Date : June 2000
Actual Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Warfarin
Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
Drug: Warfarin
Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
Other Name: Coumadin

Active Comparator: Aspirin
Aspirin 325 mg plus placebo warfarin
Drug: Aspirin
Aspirin 325 mg once a day; placebo warfarin once a day

Primary Outcome Measures :
  1. Recurrent ischemic stroke and death [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 30-85
  • Ischemic stroke within 30 days
  • Glasgow outcome scale ≥ 3
  • No contraindications to warfarin/aspirin

Exclusion Criteria:

  • Basal INR > 1.4
  • Post-procedural stroke
  • Severe carotid atherosclerosis
  • Cardioembolic stroke
  • Contraindications to transesophageal echocardiography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697151

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United States, New York
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Shunichi Homma, MD Columbia University
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shunichi Homma,MD - Principal Investigator, Columbia University Identifier: NCT00697151    
Other Study ID Numbers: 6372
R01NS032525 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011
Keywords provided by Columbia University:
cerebrovascular diseases
ischemic stroke
patent foramen ovale
transesophageal echocardiography
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors