Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

Completed · Phase 3

Conditions studied: Myocardial Infarction, Acute ST-Segment Elevation

In brief

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

Key facts

Study ID

NCT00077792

Run by

Sanofi

People needed

20506

Starts

2002-10-01

Expected to finish

2006-12-01

Last updated by the study team

2009-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with ST-segment elevation acute myocardial infarction meeting all of the following 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

You may not qualify if…

• Cardiovascular
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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