Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI

Inclusion criteria

• Patients >18 years of age.
• Symptoms of STEMI for at least 30 min within previous 12 hours AND

• ST-segment elevation in at least 2 contiguous leads or new Left Branch Bundle Block (LBBB), OR existing LBBB with positive troponin
• Residual high grade stenosis and associated abnormalities in regional wall motion.
• Planned primary PCI in native coronary vessel.

Exclusion criteria

• Confirmed pregnancy
• Fibrinolytic therapy - Any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours
• Culprit lesion within SVG or bypass conduit
• Dependency on renal dialysis
• Administration of LMWH within 8 hours prior to PCI
• Administration of abciximab within 7 days prior to PCI
• Administration of eptifibatide or tirofiban within 12 hours prior to PCI
• Warfarin MUST BE discontinued prior to procedure, and the INR must be ⎕1.5, or the PT<15,
• Heparin. If heparin is administered in the ER as long as it is discontinued at least 30 minutes prior to procedure, OR ACT <250, a patient may be enrolled. No clotting measurements are required if patient received heparin ⎕30 minutes prior to the initiation of bivalirudin.
• Allergy to heparin or bivalirudin, or known sensitivity to any component of the products
• Allergy to aspirin, clopidogrel, or abciximab
• Contraindication to abciximab
• Angiomax within 24 hours prior to study drug administration
• Neurosurgery with three months
• Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (BP >180/110 mm Hg)
• Cardiogenic shock (SBP <80 for >30 min or a need for intravenous pressors)
• Stroke within three months
• Any hemorrhagic diathesis
• Life expectancy <1 year
• Participation in another clinical trial