Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)

Inclusion criteria

• Be aged >=18 years at the time of randomization.
• Have symptoms which include at least 10 minutes of angina or anginal equivalent that the investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac ischemia should not be enrolled).
• Meet at least one of the following criteria for UA/NSTEMI:

• All of the following four features: *Age >= to 65 years; *aspirin taken within the last 7 days; *two or more episodes of angina in the last 24 hours; *three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR
• ECG changes: New or presumably new ST-segment depression >=0.1 MV (>=1mm), or transient (<30 minutes) ST-segment elevation >=0.1MV (>=1mm) in at least 2 contiguous leads, OR
• Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater than the site's upper limit of normal (ULN) OR
• History of coronary artery disease with documentation of one of the following: *prior angiography (coronary stenosis of >50%); *prior PCI or Coronary Artery Bypass Grafting (CABG); *prior definite, documented myocardial infarction.
• Provide written informed consent before initiation of any study related procedures.

Exclusion criteria

• Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization.
• ST segment elevation of >1 mm in 2 contiguous ECG leads lasting for >30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
• Cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump).
• Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the last 2 years, or any prior stroke with residual neurologic deficit. Gastrointestinal or genitourinary bleeding within the last 2-weeks.
• Platelet count <100,000 cells/mm3 at baseline, or history of heparin induced thrombocytopenia
• Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline INR is < 1.5 times control.
• Allergy to pork or pork products.
• Patients who have been started on and received 2 or more doses of low molecular weight heparin for the current admission prior to randomization (patients who have received one dose of low molecular weight heparin may still be enrolled.
• Patients who have been started on bivalirudin in the 6 hours prior to randomization
• Thrombolytic therapy or abciximab use within the last 24 hours.
• Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot be discontinued.
• Patients on Arixtra (fondaparinux).
• Absolute contraindication or allergy to:

• any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin
• both abciximab and eptifibatide
• both eptifibatide and tirofiban
• iodinated contrast which cannot be pre-medicated
• Contraindications to angiography, including but not limited to severe peripheral vascular disease.
• Angina from secondary causes.
• Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
• Calculated serum creatinine clearance < 30 mL/min (Determined by the Cockcroft Gault formula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x [Creatinine in mg/dL]). For women, multiply by 0.85.
• Previous enrollment in this study.
• Patients currently enrolled in another investigational drug study that has not completed the follow-up phase.