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Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00697151
First received: June 11, 2008
Last updated: September 14, 2011
Last verified: September 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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
Other Name: Aspirin

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697151

Locations
United States, New York
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Shunichi Homma, MD Columbia University
  More Information

Publications:
Additional 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
Study First Received: June 11, 2008
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Aspirin
Cerebral Infarction
Foramen Ovale, Patent
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Nervous System Diseases
Vascular Diseases
Warfarin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014