Study Design

Study Design:

Patients Enrolled: 483
NYHA Class: not reported
Mean Follow Up: 30 days
Mean Patient Age: not reported
Female: 18
Mean Ejection Fraction: not reported

Patient Populations:

Age 21-75 years Qualifying episode of ischemic discomfort of >=30 minutes duration within the prior 6 hours ST-segment elevation of >=1 mV in 2 limb leads or >=0.2 mV ST-segment elevation in 2 contiguous precordial leads

Exclusions:

LBBB, intraventricular conduction defect, or paced rhythm; MI or PCI within the prior 7 days; previous CABG surgery, cardiogenic shock or pulmonary edema; systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg; prior history of stroke, transient ischemic attack, or CNS structural damage; active bleeding or history of hemorrhagic diathesis within prior year; active peptic ulcer disease within 2 months, major surgery within prior 3 months; platelet disorder or thrombocytopenia; need for long-term anticoagulation therapy; treatment with abciximab within the prior 7 days or eptifibatide or tirofiban within the prior 24 hours; known allergy to aspirin or any study drug; treatment with an oral anticoagulant within the prior 5 days, thrombolytic therapy within the prior 7 days, or treatment with any LMWH or UFH within 24 hours prior to randomization; inability to undergo cardiac catheterization; MI precipitated by correctable factors; severe liver disease or estimated creatinine clearance <=30 mL/min.

Primary Endpoints:

TIMI grade 3 flow at 60 minutes in the infarct related artery.

Secondary Endpoints:

TIMI frame count at 60 minutes in the infarct related artery ECG resolution Composite end point of death and recurrent MI at 30 days TIMI major hemorrhage at 30 days

Drug/Procedures Used:

Patients were randomized to either standard reperfusion (full-dose TNK) or combination therapy (half-dose TNK plus abciximab) and to either a control group using UFH or an experimental group using enoxaparin. Full dose TNK bolus was 0.53 mg/kg; combination therapy was half dose TNK bolus of 0.27 mg/kg and abciximab dose of 0.25 mg/kg bolus and 12-hour infusion of 0.125 mg/kg/min. UFH dose was 60 U/kg bolus followed by 12 U/kg/h infusion for >=36 hrs for patients in the standard reperfusion arm; UFH dose was 40 U/kg bolus followed by 7 U/kg/h infusion for >=36 hrs for patients in the combination arm. Both UFH regimens were titrated to aPTT of 1.5-2.5 times control. Enoxaparin dosing was 1.0 mg/kg SC every 12 hours for up to 8 days +/- initial 30 mg IV bolus for patients in the standard reperfusion arm; dosing was 0.3-0.75 mg/kg SC every 12 hours for up to 8 days +/- initial 30 mg IV bolus for patients in the combination arm.

Concomitant Medications:

Aspirin