Acute ST-Segment Elevation, Myocardial Infarction
Conditions
Keywords
Receiving fibrinolytic therapy
Brief 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
Interventions
DRUGEnoxaparin sodium (XRP4563)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality and non-fatal myocardial re-infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Uruguay
Outcome results
None listed