Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-28 @ 8:14 AM
Study NCT ID:
NCT00714961
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2008-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-24', 'studyFirstSubmitDate': '2008-07-10', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy: composite of an included infarct-related artery on the pre-discharge angiogram, or death or recurrent MI by the time of the start of coronary angiography'}, {'measure': 'safety: TIMI major bleeding'}], 'secondaryOutcomes': [{'measure': 'Angiographic, clinical and electrocardiographic outcomes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Coronary Syndromes']}, 'referencesModule': {'references': [{'pmid': '15758000', 'type': 'RESULT', 'citation': 'Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.'}, {'pmid': '20102867', 'type': 'DERIVED', 'citation': 'Harkness JR, Sabatine MS, Braunwald E, Morrow DA, Sloan S, Wiviott SD, Giugliano RP, Antman EM, Cannon CP, Scirica BM. Extent of ST-segment resolution after fibrinolysis adds improved risk stratification to clinical risk score for ST-segment elevation myocardial infarction. Am Heart J. 2010 Jan;159(1):55-62. doi: 10.1016/j.ahj.2009.10.033.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination of aspirin plus clopidogrel is more effective than aspirin alone in preventing another heart attack, chest pain, stroke or death in people who have already had a heart attack that was treated with fibrinolytic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STEMI within 12 hours of randomization\n* Planned treatment with a fibrinolytic agent and aspirin\n\nExclusion Criteria:\n\n* Intention of performing coronary angiography within 48 hours of fibrinolysis\n* Treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, or planned treatment with clopidogrel or ticlopidine.\n* Contraindication to fibrinolysis\n* Planned use of a glycoprotein IIb/IIIa inhibitor\n* Prior CABG\n* Evidence of cardiogenic shock or acute pulmonary edema requiring intubation or an intraaortic balloon pump\n* Known renal or hepatic insufficiency'}, 'identificationModule': {'nctId': 'NCT00714961', 'acronym': 'CLARITY-TIMI28', 'briefTitle': 'Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Clopidogrel Plus Acetylsalicylic Acid (ASA) Versus ASA Alone in Subjects With Acute ST Elevation Myocardial Infarction (STEMI) Treated With Fibrinolytic Therapy', 'orgStudyIdInfo': {'id': 'EFC5133'}, 'secondaryIdInfos': [{'id': 'CV149-015'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Clopidogrel (SR25990)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clopidogrel (SR25990)', 'type': 'DRUG', 'description': 'plus acetylsalicylic acid (ASA)', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'plus acetylsalicylic acid (ASA)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Macquarie Park', 'country': 'Australia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'sanofi-aventis Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Diegem', 'country': 'Belgium', 'facility': 'sanofi-aventis Belgium', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'sanofi-aventis Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'sanofi-aventis Canada', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Paris', 'country': 'France', 'facility': 'sanofi-aventis France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'sanofi-aventis Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Sanofi-Aventis Hungaria', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Netanya', 'country': 'Israel', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'sanofi-aventis Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Mexico', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'sanofi-aventis Netherlands', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'sanofi-aventis Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'sanofi-aventis South Africa', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'sanofi-aventis Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bromma', 'country': 'Sweden', 'facility': 'sanofi-aventis Sweden', 'geoPoint': {'lat': 59.34, 'lon': 17.94}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'sanofi-aventis UK', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Eugene Braunwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital, Boston, MA, USA"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}