Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 3:53 AM
Study NCT ID:
NCT00129805
Status:
COMPLETED
Last Update Posted:
2008-08-19
First Post:
2005-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C064294', 'term': 'sarpogrelate'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-18', 'studyFirstSubmitDate': '2005-08-11', 'studyFirstSubmitQcDate': '2005-08-11', 'lastUpdatePostDateStruct': {'date': '2008-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of cerebral infarction'}], 'secondaryOutcomes': [{'measure': 'intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '18388340', 'type': 'RESULT', 'citation': 'Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.\n\nS-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cerebral infarction except cardiac source of embolism\n* Onset ≧ 1 week to ≦ 6 months before randomization\n* Neurological signs persisting ≧ 1 day from onset\n* Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site\n* Age ≧ 20 years\n* Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg\n\nExclusion Criteria:\n\n* Functional outcome at randomization: Modified Rankin Scale = 4, 5\n* Previous or planned vascular surgery for cerebral infarction\n* History of intracranial hemorrhage\n* History of systemic bleeding, or other history of bleeding diathesis or coagulopathy\n* Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)\n* Pregnant or possibly pregnant women, or nursing mothers\n* History of sarpogrelate and aspirin sensitivity\n* Treating malignant tumor or treated within 5 years\n* Current peptic ulceration'}, 'identificationModule': {'nctId': 'NCT00129805', 'briefTitle': 'Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial', 'orgStudyIdInfo': {'id': 'MCI9042-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCI-9042', 'interventionNames': ['Drug: MCI-9042']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'MCI-9042', 'type': 'DRUG', 'otherNames': ['Sarpogrelate(INN)', 'ANPLAG(R)'], 'armGroupLabels': ['MCI-9042']}, {'name': 'Aspirin', 'type': 'DRUG', 'armGroupLabels': ['Aspirin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yukito Shinohara, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'General Manager, Clinical Research Department I', 'oldOrganization': 'Mitsubishi Tanabe Pharma Corporation'}}}}