Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT00027066
Status:
COMPLETED
Last Update Posted:
2011-06-17
First Post:
2001-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Warfarin Versus Aspirin Recurrent Stroke Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2001-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-16', 'studyFirstSubmitDate': '2001-11-20', 'studyFirstSubmitQcDate': '2001-11-20', 'lastUpdatePostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'aspirin', 'warfarin'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nejm.org/doi/pdf/10.1056/NEJMoa011258', 'label': 'NEJM Article'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.', 'detailedDescription': 'This study compared aspirin to warfarin to determine optimal therapy for the prevention of recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the final stages of the most common type of stroke due to blockage of the vessels that supply oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits circulating clotting proteins in the blood. Numerous previous studies have proven that use of aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin versus warfarin for stroke prevention has been the thinking among clinicians that warfarin may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it has greater side effects, increased risk of hemorrhage, and higher costs due to the need for blood tests to monitor the treatment effect for patients.\n\nTo make the aspirin and warfarin arms of the study as unbiased as possible, the investigators matched both groups of patients for primary stroke severity, age, gender, education, and race/ethnicity. The two groups were also matched for stroke risk factors, including hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity. The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically tailored to each individual patient.\n\nThis study found that aspirin works as well as warfarin in helping to prevent recurrent strokes in most patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Acceptable candidates for warfarin therapy\n* Had an ischemic stroke within the previous 30 days\n* Had scores of 3 or more on the Glasgow Outcome Scale\n\nExclusion:\n\n* Base-line INR above the normal range (more than 1.4)\n* History of stroke due to a procedure or that was attributed to high-grade carotid stenosis for which surgery was planned\n* History of stroke associated with an inferred cardioembolic source'}, 'identificationModule': {'nctId': 'NCT00027066', 'briefTitle': 'Warfarin Versus Aspirin Recurrent Stroke Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke', 'orgStudyIdInfo': {'id': 'R01NS028371', 'link': 'https://reporter.nih.gov/quickSearch/R01NS028371', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NS028371', 'link': 'https://reporter.nih.gov/quickSearch/R01NS028371', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Warfarin and Aspirin Placebo', 'description': 'One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.', 'interventionNames': ['Drug: Active Warfarin', 'Drug: Aspirin placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Aspirin and Warfarin Placebo', 'description': 'One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.', 'interventionNames': ['Drug: Active Aspirin', 'Drug: Warfarin placebo']}], 'interventions': [{'name': 'Active Aspirin', 'type': 'DRUG', 'description': '325mg tablet daily', 'armGroupLabels': ['Active Aspirin and Warfarin Placebo']}, {'name': 'Active Warfarin', 'type': 'DRUG', 'description': '2mg scored tablet daily', 'armGroupLabels': ['Active Warfarin and Aspirin Placebo']}, {'name': 'Aspirin placebo', 'type': 'DRUG', 'description': '325mg aspirin placebo pill', 'armGroupLabels': ['Active Warfarin and Aspirin Placebo']}, {'name': 'Warfarin placebo', 'type': 'DRUG', 'description': '2mg scored placebo tablet', 'armGroupLabels': ['Active Aspirin and Warfarin Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Health Sciences', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'J. P. Mohr, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Jay Preston Mohr, MD', 'oldOrganization': 'Columbia University'}}}}