Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
NCT ID: NCT00077792
Last Updated: 2009-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20506 participants
INTERVENTIONAL
2002-10-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Enoxaparin sodium (XRP4563)
Eligibility Criteria
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Inclusion Criteria
* 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)
* Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization
* 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
* Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase
* Written informed consent will be obtained
Exclusion Criteria
* Evidence of cardiogenic shock at randomization
* Acute pericarditis
* History or symptoms suggestive of aortic dissection
* MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine
Hemorrhagic Risk
* Any minor head trauma or any other trauma occurring after the index acute myocardial infarction
* Active or recent (\< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria.
* Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
* Any single reliable recording of systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg prior to randomization
* Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease
* Any known structural damage or other pathologic process involving the central nervous system
* Any head trauma within 6 months prior to randomization
* Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization
* Traumatic or prolonged cardiopulmonary resuscitation (\> 2 minutes) within 2 weeks prior to randomization
* Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization
* Acute peptic ulcer disease within 3 months prior to randomization
Prior or Concomitant Pharmacologic Therapy
* Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide (Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization
* Current therapy with oral anticoagulants, or an International Normalized Ratio of \>1.5
* Administration of a low molecular weight heparin within 8 hours prior to randomization.
* Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products
* Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase)
General
* Known platelet count \<100,000 cells/microL or history of heparin-induced thrombocytopenia
* Known clinically significant anemia (Hemoglobin \<10 g/dL which is \< 6.2 mmol/L)
* 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.
* Advanced neoplastic or other life-threatening disease with a life expectancy of \<12 months
* Pregnancy or parturition within the last 90 days or currently breast feeding
* Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test.
* Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25
* History of drug or alcohol abuse
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
sanofi-aventis administrative Office
Buenos Aires, , Argentina
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, , Australia
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Minsk, , Belarus
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Sofia, , Bulgaria
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Shangaï, , China
Sanofi-Aventis Administrative Office
Zagreb, , Croatia
Sanofi-Aventis Administrative Office
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Tallinn, , Estonia
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi- Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Athens, , Greece
Sanofi-Aventis Administrative Office
Causeway Bay, , Hong Kong
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Dublin, , Ireland
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Amman, , Jordan
Sanofi-Aventis Administrative Office
Riga, , Latvia
Sanofi-Aventis Administrative Office
Beirut, , Lebanon
Sanofi-Aventis Administrative Office
Vilnius, , Lithuania
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Lysaker, , Norway
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Singapore, , Singapore
Sanofi-Aventis Administrative Office
Bratislava, , Slovakia
Sanofi-Aventis Administrative Office
Midrand, , South Africa
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Bangkok, , Thailand
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Administrative Office
Kiev, , Ukraine
Sanofi-aventis adminsitrative office
Guildford Surrey, , United Kingdom
Sanofi-Aventis Administrative Office
Montevideo, , Uruguay
Countries
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References
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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.
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.
Other Identifiers
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XRP4563B/3001
Identifier Type: -
Identifier Source: secondary_id
EFC6147
Identifier Type: -
Identifier Source: org_study_id
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