Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
The primary objectives of the trial are:
- 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.
- 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.
Drug: Unfractionated heparin
Device: Bare metal stent
Device: Paclitaxel-eluting stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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™)|
- Pharmacology Arm - Primary [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Composite of major adverse ischemic cardiac events and major bleeding (bleeding adjudicated as not related to CABG) = Composite net clinical benefit endpoint.
- Stent Arm - Primary Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Ischemic target lesion revascularization
- Stent Arm - Primary Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Composite rate of death, reinfarction, stroke or stent thrombosis
- Pharmacology Arm - Major Secondary [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Major adverse ischemic events (death, reinfarction, stroke or ischemic target vessel revascularization).
- Pharmacology Arm - Major Secondary [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Major bleeding
- Stent Arm - Major Secondary [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]Analysis segment binary angiographic restenosis (13 month angiographic subset).
|Study Start Date:||March 2005|
|Study Completion Date:||November 2010|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Pharmacology Arm
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
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).
Other Name: AngiomaxDrug: Unfractionated heparin
60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
Other Name: Heparin Sodium
Active Comparator: Stent Arm
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
Device: Bare metal stent
Uncoated bare metal stent
Other Name: EXPRESS2™Device: Paclitaxel-eluting stent
slow rate-release paclitaxel-eluting stent
Other Name: TAXUS™
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™).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433966
|United States, North Carolina|
|LeBauer CV Research Foundation|
|Greensboro, North Carolina, United States, 27401|
|Principal Investigator:||Gregg W Stone, MD||CardioVascular Research Foundation, Korea|
|Study Director:||Roxana Mehran, MD||CardioVascular Research Foundation, Korea|