Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 6:30 AM
Study NCT ID:
NCT01094457
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2010-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077407', 'term': 'Cilostazol'}], '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'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major ischemic cardiovascular events', 'timeFrame': '1 year', 'description': 'defined as a composite of cardiac death, myocardial infarction or stroke'}], 'secondaryOutcomes': [{'measure': 'Stent thrombosis', 'timeFrame': '1 year', 'description': 'according to ARC definition'}, {'measure': 'major adverse cardiac and cerebral events(MACCE)', 'timeFrame': '1 year', 'description': 'defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke'}, {'measure': 'Hemorrhagic events', 'timeFrame': 'within 1 year', 'description': 'according to TIMI bleeding definition'}, {'measure': 'reduction in ADP induced platelet aggregation', 'timeFrame': '30 days', 'description': 'assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antiplatelet therapy', 'clopidogrel low responsiveness', 'acute coronary syndromes', 'percutaneous coronary intervention', 'cilostazol'], 'conditions': ['Acute Coronary Syndromes', 'Percutaneous Coronary Intervention', 'Clopidogrel Low Responsiveness']}, 'descriptionModule': {'briefSummary': 'Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criterial:\n\n* aged 35 to 75 years\n* acute coronary syndromes\n* underwent successful coronary stent implantation\n* informed consent\n\nExclusion Criteria:\n\n* contraindications to antiplatelet therapy\n* history of intracranial bleeding\n* known bleeding disorders\n* severe liver or kidney disease\n* pregnancy\n* left main coronary artery disease\n* planned non cardiac surgery within 1 year\n* end stage of other serious disease with life expectancy less than 1 year\n* heart failure with NYHA grade 3 to 4'}, 'identificationModule': {'nctId': 'NCT01094457', 'briefTitle': 'Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'orgStudyIdInfo': {'id': '825004-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard group', 'description': 'patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d', 'interventionNames': ['Drug: aspirin, clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'intensive group', 'description': 'patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA', 'interventionNames': ['Drug: aspirin, clopidogrel, cilostazol']}], 'interventions': [{'name': 'aspirin, clopidogrel', 'type': 'DRUG', 'description': 'patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year', 'armGroupLabels': ['standard group']}, {'name': 'aspirin, clopidogrel, cilostazol', 'type': 'DRUG', 'description': 'Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.', 'armGroupLabels': ['intensive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': '463 Hospital of PLA', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110840', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shenyang Northern Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Yaling Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenyang Northern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice president', 'investigatorFullName': 'Yaling Han', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}