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

INCLUSION CRITERIA: Patients with ST-segment elevation acute myocardial infarction meeting all of the followingcriteria:

• Male or non-pregnant female greater than or equal to 18 years of age (depending onlocal regulations, minimal age can vary between 18 and 21 years)

• Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest lessthan 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 morecontiguous precordial leads, or left bundle-branch block

• Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase

• Written informed consent will be obtained

EXCLUSION CRITERIA: 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, severeanemia, hyperthyroidism, cocaine, or amphetamine Hemorrhagic Risk

• Any minor head trauma or any other trauma occurring after the index acute myocardialinfarction

• Active or recent (< 3 months) bleeding including gastrointestinal bleeding, knownpresence of occult blood in the stool, or gross hematuria.

• Any history of bleeding diathesis, coagulopathy, platelet disorder, orthrombocytopenia

• Any single reliable recording of systolic blood pressure >180 mm Hg and/or diastolicblood pressure >110 mm Hg prior to randomization

• Any history of stroke or transient ischemic attack; any history of hemorrhagiccerebrovascular disease

• Any known structural damage or other pathologic process involving the central nervoussystem

• 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 weeksprior to randomization

• Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior torandomization

• 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 torandomization

• Current therapy with oral anticoagulants, or an International Normalized Ratio of >1.5

• Administration of a low molecular weight heparin within 8 hours prior torandomization.

• Known hypersensitivity to low molecular weight heparins, unfractionated heparin orheparin-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-inducedthrombocytopenia

• 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 <12months

• Pregnancy or parturition within the last 90 days or currently breast feeding

• Women of childbearing potential except if post-menopausal, surgically sterile or usingaccepted method(s) of birth control or having a negative pregnancy test.

• Treatment with other investigational agents in the last 30 days before study entry orprevious enrollment in ExTRACT-TIMI 25

• History of drug or alcohol abuse

• Mental condition rendering the patient unable to understand the nature, scope, andpossible consequences of the study

• Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inabilityto return for follow-up visits, and who are unlikely to complete the study