Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433966
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2007-02-09
Brief Title:
Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Sponsor:
Cardiovascular Research Foundation New York
Organization:
Cardiovascular Research Foundation New York
Study Overview
Official Title:
Dual Arm Factorial Randomized Trial in Patients wST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin Routine GP IIbIIIa Inhibition or Bivalirudin Bail-out GP IIbIIIa 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
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of the trial are
1 To establish the safety and efficacy of the use of bivalirudin bail-out GP IIbIIIa inhibitors compared to the use of unfractionated heparin GP IIbIIIa 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
1 To establish the safety and efficacy of the use of bivalirudin bail-out GP IIbIIIa inhibitors compared to the use of unfractionated heparin GP IIbIIIa 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 11 in the emergency room to a anticoagulation with unfractionated heparin plus routine GP IIbIIIa inhibition vs b bivalirudin and bail-out GP IIbIIIa inhibition Following angiography patients with lesions eligible for stenting will then undergo a second randomization 31 to stent implantation with either a a slow rate-release paclitaxel-eluting stent TAXUS or b an otherwise identical uncoated bare metal stent EXPRESS2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None