Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiovascular Research Foundation, New York
• Collaborators: Boston Scientific Corporation; The Medicines Company
• Treatments: Albumin-Bound Paclitaxel; Bivalirudin; Calcium heparin; Heparin; Hirudins; Paclitaxel

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.