Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-31 @ 8:00 PM
Study NCT ID:
NCT01233167
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2010-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5232}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2010-11-01', 'studyFirstSubmitQcDate': '2010-11-02', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'one year'}, {'measure': 'nonfatal myocardial infarction', 'timeFrame': 'one year'}, {'measure': 'clinical-driven target vessel revascularization', 'timeFrame': 'one year'}, {'measure': 'cardiac death', 'timeFrame': 'one year'}, {'measure': 'stent thrombosis', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'death', 'timeFrame': 'one year'}, {'measure': 'myocardial infarction', 'timeFrame': 'one year'}, {'measure': 'any repeat revascularization', 'timeFrame': 'one year'}, {'measure': 'strokes', 'timeFrame': 'one year'}, {'measure': 'dialysis/hemofiltration', 'timeFrame': 'one year'}, {'measure': 'bleeding events', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dual antiplatelet therapy', 'sirolimus drug-eluting stent', 'major adverse cardiac events', 'bleeding'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.', 'detailedDescription': 'It is not clear that dual antiplatelet therapy is better than aspirin beyond 12-months period patients receiving sirolimus drug-eluting stent implantation. If aspirin plus clopidogrel reduced MACE rates without increasing blood events, the investigators will evaluate risk-benefit ratio. The investigators will observe all cause mortality, nonfatal myocardial infarction, or clinical-driven target vessel revascularization TVR in a 1-year trial duration. In addition, strokes, stent thrombosis, cardiac re-hospitalizations, dialysis/hemofiltration, duration of hospitalization and bleeding events will be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years of older.\n* The latest PCI with DES implantation before 12 months (stents must be one or more sirolimus-eluting stents).\n* Angiographically confirmed major epicardial vessels (\\>=2.5mm in diameter) without significant stenosis or restenosis (\\>=50%).\n* Geographically accessible and willing to come in for required study visits.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* The patient has a known hypersensitivity or contraindication to aspirin and clopidogrel.\n* Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment and within 12 months.\n* EF\\<35% within 12 months.\n* Severe cardiac valves disease, or idiopathic cardiomyopathy such as dilated cardiomyopathy, hypotrophic cardiomyopathy. Other severe system diseases.\n* Previous ACS within 12 months.\n* Previous stroke or transient ischemia attack within 12 months.\n* Previous myocardial infarction and clinical-driven target vessel revascularization within 12 months.\n* Current enrollment in another clinical trial.\n* Suspected pregnancy.\n* Big bleeding events within 12 months.\n* Planned surgical procedure.\n* Previous other type DES implantation or BMS implantation history.\n* Extra-cardiac stent implantation history.\n* Current or planned dialysis.\n* The patient has a known hypersensitivity or contraindication to statins.\n* Current or planned high dose and long-term glucocorticoid treatment.\n* that is expected to limit survival to less than 1 years.'}, 'identificationModule': {'nctId': 'NCT01233167', 'acronym': 'EASTS', 'briefTitle': 'Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation', 'orgStudyIdInfo': {'id': 'SRRSH-CVD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'clopidogrel', 'interventionNames': ['Drug: clopidogrel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'steply discontinued clopidogrel', 'interventionNames': ['Drug: clopidogrel and placebo']}], 'interventions': [{'name': 'clopidogrel', 'type': 'DRUG', 'description': 'clopidogrel 75 mg po per day for 12 months', 'armGroupLabels': ['clopidogrel']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo 75mg po per day for 12 months', 'armGroupLabels': ['placebo']}, {'name': 'clopidogrel and placebo', 'type': 'DRUG', 'description': 'clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months', 'armGroupLabels': ['steply discontinued clopidogrel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'He Huang, Doctor of Medicine', 'role': 'CONTACT', 'email': 'huanghell@163.com', 'phone': '860571-86006246'}, {'name': 'Guo-sheng Fu, Doctor of Philosopy', 'role': 'CONTACT', 'email': 'fugs64@gmail.com', 'phone': '860571-86006490'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guosheng Fu, director of cardiovascular department', 'oldOrganization': 'Sir Run Run Shaw Hospital, College of medicine, Zhejiang University'}}}}