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Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

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ClinicalTrials.gov Identifier: NCT00697151
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : September 15, 2011
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Columbia University

June 11, 2008
June 13, 2008
September 15, 2011
June 1993
June 2000   (Final data collection date for primary outcome measure)
Recurrent ischemic stroke and death [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00697151 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Patent Foramen Ovale in Cryptogenic Stroke Study
Patent Foramen Ovale in Cryptogenic Stroke Study
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Ischemic Stroke
  • Patent Foramen Ovale
  • 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
  • Drug: Aspirin
    Aspirin 325 mg once a day; placebo warfarin once a day
  • Active Comparator: Warfarin
    Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
    Intervention: Drug: Warfarin
  • Active Comparator: Aspirin
    Aspirin 325 mg plus placebo warfarin
    Intervention: Drug: Aspirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
Same as current
June 2000
June 2000   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00697151
6372
R01NS032525 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Shunichi Homma,MD - Principal Investigator, Columbia University
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Shunichi Homma, MD Columbia University
Columbia University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP