Myocardial Infarction, Myocardial Ischemia, Unstable Angina
Conditions
Keywords
Acute coronary syndromes, non-ST-segment elevation
Brief summary
Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.
Interventions
DRUGenoxaparin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or nonpregnant female greater than or equal to 18 years old * Ischemic pain originating or persisting at rest, or its clinical equivalent, lasting greater than or equal to 10 minutes and occurring within the 24 hours before enrollment * At least 2 of the following: * ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (greater than or equal to 1 mm), or transient (\<30 minutes) ST-segment elevation greater than or equal to 0.1 mV (greater than or equal to 1 mm) in at least 2 contiguous leads * Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin I or T greater than the established criteria at each site OR creatine kinase CK-MB level greater than the site's upper limit of normal * Age greater than or equal to 60 years
Exclusion criteria
* Known or suspected pregnancy * Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (\<1 month) trauma or major surgery (including bypass surgery); active bleeding * Impaired hemostasis: known International Normalized Ratio (INR) \>1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/mL), or history of thrombocytopenia with GP IIb/IIIa inhibitor therapy, heparin, or enoxaparin * Angina from a secondary cause such as severe, uncontrolled hypertension (systolic blood pressure \>180 mm Hg despite treatment); anemia; valvular disease; congenital heart disease; hypertrophic cardiomyopathy; restrictive or constrictive cardiomyopathy; thyrotoxicosis * PCI within the past 24 hours, not including coronary angiography only * Allergy to pork or pork products * Contraindications to UFH or LMWH * Recent (\<48 hours) or planned spinal/epidural anesthesia or puncture * Thrombolytic therapy within the preceding 24 hours * Other serious diseases, including severe liver disease or renal failure \[creatinine clearance \<30 mL/min * Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial * Inability to give informed consent or high likelihood of being unavailable for follow-up * Not a candidate for intervention, (angiography or PCI) * Treatment with a direct thrombin inhibitor or a low molecular weight heparin other than enoxaparin in the 7 days preceding enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the composite endpoint of all-cause mortality or the first clinical events committee (CEC)-adjudicated nonfatal myocardial infarction | within 30 days after randomization |
| To measure the incidence of major bleeding. | during the index hospitalization |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of minor and all bleeding | during the index hospitalization |
| To evaluate the combined and individual incidence of all-cause mortality, clinical events committee (CEC)-adjudicated nonfatal MI, stroke, or recurrent ischemia that required revascularization | within 14 and 30 days after randomization |
| To evaluate the incidence of all-cause mortality | within 6 months and 1 year after randomization |
| To evaluate the combined incidence of all-cause mortality or CEC-adjudicated nonfatal MI | within 14 days and all-cause mortality or nonfatal MI within 6 months after randomization |
Countries
United States
Outcome results
None listed