Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 10:25 PM
Study NCT ID:
NCT00077792
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2004-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-17', 'studyFirstSubmitDate': '2004-02-12', 'studyFirstSubmitQcDate': '2004-02-13', 'lastUpdatePostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of all-cause mortality and non-fatal myocardial re-infarction'}], 'secondaryOutcomes': [{'measure': 'Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke'}]}, 'conditionsModule': {'keywords': ['Receiving fibrinolytic therapy'], 'conditions': ['Myocardial Infarction', 'Acute ST-Segment Elevation']}, 'referencesModule': {'references': [{'pmid': '16537665', 'type': 'RESULT', 'citation': 'Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, Lopez-Sendon JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006 Apr 6;354(14):1477-88. doi: 10.1056/NEJMoa060898. Epub 2006 Mar 14.'}, {'pmid': '20400762', 'type': 'DERIVED', 'citation': 'Morrow DA, Antman EM, Fox KA, White HD, Giugliano R, Murphy SA, McCabe CH, Braunwald E; ExTRACT-TIMI 25 Investigators. One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial. Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nPatients with ST-segment elevation acute myocardial infarction meeting all of the following criteria:\n\n* Male or non-pregnant female greater than or equal to 18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years)\n* Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization\n* ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in two (2) or more contiguous precordial leads, or left bundle-branch block\n* Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase\n* Written informed consent will be obtained\n\nEXCLUSION CRITERIA:\n\nCardiovascular\n\n* Evidence of cardiogenic shock at randomization\n* Acute pericarditis\n* History or symptoms suggestive of aortic dissection\n* MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine\n\nHemorrhagic Risk\n\n* Any minor head trauma or any other trauma occurring after the index acute myocardial infarction\n* Active or recent (\\< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria.\n* Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia\n* Any single reliable recording of systolic blood pressure \\>180 mm Hg and/or diastolic blood pressure \\>110 mm Hg prior to randomization\n* Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease\n* Any known structural damage or other pathologic process involving the central nervous system\n* Any head trauma within 6 months prior to randomization\n* Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization\n* Traumatic or prolonged cardiopulmonary resuscitation (\\> 2 minutes) within 2 weeks prior to randomization\n* Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization\n* Acute peptic ulcer disease within 3 months prior to randomization\n\nPrior or Concomitant Pharmacologic Therapy\n\n* Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide (Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization\n* Current therapy with oral anticoagulants, or an International Normalized Ratio of \\>1.5\n* Administration of a low molecular weight heparin within 8 hours prior to randomization.\n* Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products\n* Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase)\n\nGeneral\n\n* Known platelet count \\<100,000 cells/microL or history of heparin-induced thrombocytopenia\n* Known clinically significant anemia (Hemoglobin \\<10 g/dL which is \\< 6.2 mmol/L)\n* Known renal insufficiency with serum creatinine \\>220 mmol/L (2.5 mg/dL) for men and \\>175 mmol/L (2.0 mg/dL) for women when assessed prior to baseline examination.\n* Advanced neoplastic or other life-threatening disease with a life expectancy of \\<12 months\n* Pregnancy or parturition within the last 90 days or currently breast feeding\n* Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test.\n* Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25\n* History of drug or alcohol abuse\n* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study\n* Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and who are unlikely to complete the study'}, 'identificationModule': {'nctId': 'NCT00077792', 'briefTitle': 'Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the 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