NCT00433966

Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary Angioplasty With Stent Implantation With Either a Slow Rate-release Paclitaxel-eluting Stent (TAXUS™) or Uncoated Bare Metal Stent (EXPRESS2™)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,602 (actual)
• Sponsor: Cardiovascular Research Foundation, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions eligible for stenting will then undergo a second randomization (3:1) to stent implantation with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise identical uncoated bare metal stent (EXPRESS2™).

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-06-01
• Completion: 2010-11-01
• First posted: 2007-02-12
• Last updated: 2017-12-04
• Results posted: 2017-12-04

Locations

1 site across 1 country: United States