Clinical trial NCT00433966 (phase 3, status: completed)
Conditions: myocardial infarction
ICD codes: I25.2, I21.9, I21.A1, I21.A9, I21.4, I22.2, I23.8
Drugs: bivalirudin, unfractionated heparin
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)CC1=CC=CC=C1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC1=CC=C(O)C=C1)C(=O)N[C@@H](CC(C)C)C(O)=O, O.O.[Al+3].[Cl-].[Zr+4].NCC([O-])=O
Eligibility 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.