Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Bivalirudin; Unfractionated heparin; Bare metal stent; Paclitaxel-eluting stent
Intervention description: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).; 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).; Uncoated bare metal stent; slow rate-release paclitaxel-eluting stent
Intervention MeSH terms: Paclitaxel; Heparin; Calcium heparin; Bivalirudin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 3602.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myocardial Infarction; Angioplasty; Myocardial Ischemia; Myocardial Reperfusion; Stents; Heart Disease

Summary:

      The primary objectives of the trial are:

        1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa
           inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in
           patients with acute myocardial infarction undergoing a primary angioplasty strategy.

        2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™
           stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.
    

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.