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Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

NCT00433966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3602

Last updated 2017-12-04

Study results available
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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.

Conditions

Interventions

DRUG

Bivalirudin

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).

DRUG

Unfractionated heparin

60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).

DEVICE

Bare metal stent

Uncoated bare metal stent

DEVICE

Paclitaxel-eluting stent

slow rate-release paclitaxel-eluting stent

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • The Medicines Company

    collaborator INDUSTRY

  • Cardiovascular Research Foundation, New York

    lead OTHER

Principal Investigators

  • Gregg W Stone, MD · CardioVascular Research Foundation

  • Roxana Mehran, MD · CardioVascular Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-06-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00433966 on ClinicalTrials.gov