Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT00147303
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2005-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2005-09-04', 'studyFirstSubmitQcDate': '2005-09-04', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '17622759', 'type': 'RESULT', 'citation': 'Uchiyama S, Ozaki Y, Satoh K, Kondo K, Nishimaru K. Effect of sarpogrelate, a 5-HT(2A) antagonist, on platelet aggregation in patients with ischemic stroke: clinical-pharmacological dose-response study. Cerebrovasc Dis. 2007;24(2-3):264-70. doi: 10.1159/000105135. Epub 2007 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.\n\nThe present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification\n2. Neurological signs persisting≧ 1 day from onset\n3. Defined onset of symptoms, and stable condition at the period of enrollment\n4. CT or MRI detection of responsible site\n5. age≧20\n6. Systolic pressure≦180 mmHg, Diastolic pressure≦110 mmHg\n7. The maximum intensity of platelet aggregation is above 15 % induced by serotonin (1µM) and epinephrine (3µM) on the day of prior to the first medication\n8. Written informed consent must be obtained from the patients before enrollment into the study\n\nExclusion Criteria:\n\n1. Functional outcome at randomization: Modified Rankin Scale=4, 5\n2. Previous or planned for vascular surgery to cerebral infarction\n3. History of intracranial hemorrhage\n4. History of systemic bleeding, or other history of bleeding diathesis or coagulopathy\n5. With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on )\n6. Treating malignant tumor\n7. Pregnant or possibly pregnant women, or nursing mothers\n8. History of sarpogrelate sensitivity\n9. Previously entered in other clinical trials within 3 months\n10. Less than 3 months since any other clinical trial\n11. Judged by investigator to be unsuitable for the study'}, 'identificationModule': {'nctId': 'NCT00147303', 'briefTitle': 'Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.', 'orgStudyIdInfo': {'id': 'MCI9042-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group L', 'description': '25mg sarpogrelate', 'interventionNames': ['Drug: MCI-9042']}, {'type': 'EXPERIMENTAL', 'label': 'group M', 'description': '50mg sarpogrelate', 'interventionNames': ['Drug: MCI-9042']}, {'type': 'EXPERIMENTAL', 'label': 'group H', 'description': '100mg sarpogrelate', 'interventionNames': ['Drug: MCI-9042']}], 'interventions': [{'name': 'MCI-9042', 'type': 'DRUG', 'armGroupLabels': ['group H', 'group L', 'group M']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shinichiro Uchiyama, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Tokyo Women's Medical University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'General Manager, Clinical Research Department I', 'oldOrganization': 'Mitsubishi Tanabe Pharma Corporation'}}}}