Ignite Creation Date:
2024-05-05 @ 10:20 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01087723
Status:
COMPLETED
Last Update Posted:
2016-02-12
First Post:
2010-03-12
Brief Title:
European Ambulance Acute Coronary Syndrome ACS Angiography Trial
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
Multi-centre Multi-national Prospective Randomised Open-label Comparison of Bivalirudin to Other Guideline Based Current Therapies Excluding Bivalirudin
Status:
COMPLETED
Status Verified Date:
2016-01
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:
EUROMAX
Brief Summary:
To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome STE-ACS intended for a primary percutaneous coronary intervention PCI management strategy presenting either via ambulance or to centers where PCI is not performed
Detailed Description:
The purpose of the trial is to show that the early administration of bivalirudin improves 30-day outcomes when compared to the current standard of care in participants with STE-ACS with an onset of symptoms of 20 minutes and 12 hours intended for a primary PCI management strategy presenting either via ambulance or to centers where PCI is not performed
All participants are to receive treatment with aspirin 150-325 milligrams mg administered orally or 250-500 mg intravenously IV followed by 75-100 milligramsday mgday for at least 1 year and a loading dose of an approved P2Y12 receptor blocker such as clopidogrel prasugrel or ticagrelor that was to be continued as per European Society of Cardiology guidelines preferably for 1 year in all participants
The primary objectives of the trial are to show that when compared with standard anti-thrombotic therapies other than bivalirudin which includes treatment with unfractionated heparin UFH and optional glycoprotein IIbIIIa inhibitor GPI that at 30 days
Bivalirudin is superior to control at reducing a composite of death and non-coronary artery bypass graft CABG-related protocol major bleeding
All participants are to receive treatment with aspirin 150-325 milligrams mg administered orally or 250-500 mg intravenously IV followed by 75-100 milligramsday mgday for at least 1 year and a loading dose of an approved P2Y12 receptor blocker such as clopidogrel prasugrel or ticagrelor that was to be continued as per European Society of Cardiology guidelines preferably for 1 year in all participants
The primary objectives of the trial are to show that when compared with standard anti-thrombotic therapies other than bivalirudin which includes treatment with unfractionated heparin UFH and optional glycoprotein IIbIIIa inhibitor GPI that at 30 days
Bivalirudin is superior to control at reducing a composite of death and non-coronary artery bypass graft CABG-related protocol major bleeding
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