Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-04-14 @ 7:19 AM
Study NCT ID:
NCT00862420
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2009-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D013988', 'term': 'Ticlopidine'}], 'ancestors': [{'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'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'}]}}, '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': 431}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-13', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)', 'timeFrame': 'Week 12 (on treatment)'}], 'secondaryOutcomes': [{'measure': 'Bleeding adverse events, Serious adverse events, Overall safety', 'timeFrame': 'Week 12, 52 (on treatment)'}, {'measure': 'Vascular events', 'timeFrame': 'Week 12, 52 (on study)'}, {'measure': 'Safety events of interest (see above)', 'timeFrame': 'Week 52 (on treatment)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Platelet aggregation inhibitors', 'Peripheral arterial disease (PAD)'], 'conditions': ['Peripheral Arterial Disease (PAD)']}, 'referencesModule': {'references': [{'pmid': '23555538', 'type': 'DERIVED', 'citation': 'Shigematsu H, Komori K, Tanemoto K, Harada Y, Nakamura M. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients. Ann Vasc Dis. 2012;5(3):364-75. doi: 10.3400/avd.oa.12.00039.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)\n\nSecondary objectives:\n\n* To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine\n* To compare the risk of vascular events of clopidogrel with ticlopidine\n* To document the long-term safety of clopidogrel for a total of 52 weeks\n* To document the vascular events of clopidogrel for a total of 52 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDocumented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):\n\n* Current intermittent claudication with Ankle Brachial Index (ABI) \\< 0.90\n* A history of intermittent claudication together with previous related intervention in a leg\n\nExclusion Criteria:\n\n* Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization\n* Bleeding diathesis, coagulopathy and present bleeding disease\n* Previous intracranial bleeding or hemorrhagic stroke\n* Uncontrolled hypertension\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00862420', 'briefTitle': 'Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks', 'orgStudyIdInfo': {'id': 'SFY10810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clopidogrel', 'description': '75 mg clopidogrel once daily from Day 1 to Week 12', 'interventionNames': ['Drug: clopidogrel (SR25990)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ticlopidine', 'description': '200 mg ticlopidine once daily from Day 1 to Week 12', 'interventionNames': ['Drug: ticlopidine']}], 'interventions': [{'name': 'clopidogrel (SR25990)', 'type': 'DRUG', 'description': 'oral administration (tablets)', 'armGroupLabels': ['Clopidogrel']}, {'name': 'ticlopidine', 'type': 'DRUG', 'description': 'oral administration (tablets)', 'armGroupLabels': ['Ticlopidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Hiroshi Shigematsu, Head Professor/MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Department of Surgery (Vascular Surgery), Tokyo Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}