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Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00697151
First Posted: June 13, 2008
Last Update Posted: September 15, 2011
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.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Columbia University
  Purpose
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 Intervention Phase
Ischemic Stroke Patent Foramen Ovale Drug: Warfarin Drug: Aspirin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

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

Enrollment: 630
Study Start Date: June 1993
Study Completion Date: June 2000
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00697151


Locations
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)
Investigators
Principal Investigator: Shunichi Homma, MD Columbia University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shunichi Homma,MD - Principal Investigator, Columbia University
ClinicalTrials.gov Identifier: NCT00697151     History of Changes
Other Study ID Numbers: 6372
R01NS032525 ( U.S. NIH Grant/Contract )
First Submitted: June 11, 2008
First Posted: June 13, 2008
Last Update Posted: September 15, 2011
Last Verified: September 2011

Keywords provided by Columbia University:
cerebrovascular diseases
ischemic stroke
patent foramen ovale
warfarin
aspirin
transesophageal echocardiography

Additional relevant MeSH terms:
Stroke
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
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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