Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting >20 minutes but <12 hours in duration;
ST-segment elevation of >1 mm in >2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1 mm in >2 contiguous anterior leads;
The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

The patient has a known hypersensitivity or contraindication to any of the following medications:

Heparin, pork or pork products
Both abciximab and eptifibatide
Aspirin
Both Clopidogrel and Ticlopidine
Bivalirudin
Paclitaxel or Taxol
The polymer components of the TAXUS™ stent (SIBS)
Stainless steel and/or
Contrast media;
Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;
Current use of coumadin;
Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
Recent history or known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL;
Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance;
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
Previous enrollment in this trial;
Patients who underwent coronary stent implantation within the past 30 days.