Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00839267
Status:
COMPLETED
Last Update Posted:
2009-02-10
First Post:
2009-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clopidogrel Efficacy and Acute Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular 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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-09', 'studyFirstSubmitDate': '2009-02-06', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower efficacy of clopidogrel determined by VASP measurement', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Higher frequency of stent thrombosis in the unstable group', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['platelet', 'VASP', 'clopidogrel', 'cardiogenic shock', 'myocardial infarction', 'percutaneous coronary intervention'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.', 'detailedDescription': 'Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial infarction and severe hemodynamic instability. Therefore we would like to compare the effect of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population of 40 consecutive patients is planned, all of them with acute myocardial infarction with ST-segment elevation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for unstable group:\n\n* acute STEMI\n* mechanical ventilation\n* the need for catecholamine support.\n\nInclusion Criteria for stable group:\n\n* acute myocardial infarction\n\nExclusion Criteria for any:\n\n* previous treatment with clopidogrel\n* clopidogrel administration during transport by ambulance\n* known intolerance to clopidogrel\n* history of thrombocytopenia (\\<150,000 platelets/ml)\n* pre-existing liver disease'}, 'identificationModule': {'nctId': 'NCT00839267', 'briefTitle': 'Clopidogrel Efficacy and Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'The Comparison of Clopidogrel Efficacy in Patients With Acute Myocardial Infarction and Severe Hemodynamic Instability to Patients With Hemodynamically Uncomplicated Myocardial Infarction', 'orgStudyIdInfo': {'id': 'CLO-OSM-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unstable', 'description': 'Patient with acute myocardial infarction plus severe hemodynamical instability. It means, on mechanical ventilation and catecholamine support'}, {'label': 'Stable', 'description': 'Patients with myocardial infarction hemodynamically completely (Killip I)stable.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Pavel Osmancik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University Prague'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pavel Osmancik', 'oldOrganization': 'Charles University Prague'}}}}