enoxaparin and thrombolysis reperfusion for acute myocardial infarction treatment thrombolysis in myocardial infarction - study 25 (extract-timi25)

Conditions: Myocardial Infarction; Acute ST-Segment Elevation

Summary: 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


Eligibility criteria:
inclusion criteria: 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 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, 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

Keywords: receiving fibrinolytic therapy