Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT00697151
Status:
COMPLETED
Last Update Posted:
2011-09-15
First Post:
2008-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patent Foramen Ovale in Cryptogenic Stroke Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2000-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-14', 'studyFirstSubmitDate': '2008-06-11', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent ischemic stroke and death', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cerebrovascular diseases', 'ischemic stroke', 'patent foramen ovale', 'warfarin', 'aspirin', 'transesophageal echocardiography'], 'conditions': ['Ischemic Stroke', 'Patent Foramen Ovale']}, 'referencesModule': {'references': [{'pmid': '12045168', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '15232117', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '13678932', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '19380621', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-85\n* Ischemic stroke within 30 days\n* Glasgow outcome scale ≥ 3\n* No contraindications to warfarin/aspirin\n\nExclusion Criteria:\n\n* Basal INR \\> 1.4\n* Post-procedural stroke\n* Severe carotid atherosclerosis\n* Cardioembolic stroke\n* Contraindications to transesophageal echocardiography'}, 'identificationModule': {'nctId': 'NCT00697151', 'acronym': 'PICSS', 'briefTitle': 'Patent Foramen Ovale in Cryptogenic Stroke Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Patent Foramen Ovale in Cryptogenic Stroke Study', 'orgStudyIdInfo': {'id': '6372'}, 'secondaryIdInfos': [{'id': 'R01NS032525', 'link': 'https://reporter.nih.gov/quickSearch/R01NS032525', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': 'Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin', 'interventionNames': ['Drug: Warfarin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'Aspirin 325 mg plus placebo warfarin', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin'], 'description': 'Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day', 'armGroupLabels': ['Warfarin']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Aspirin 325 mg once a day; placebo warfarin once a day', 'armGroupLabels': ['Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia College of Physicians and Surgeons', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Shunichi Homma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Shunichi Homma,MD - Principal Investigator', 'oldOrganization': 'Columbia University'}}}}