European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial (EUROMAX)
To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients 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 centres where PCI is not performed.
ST Segment Elevation Acute Coronary Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- A composite of death and non-CABG-related protocol major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Death at 1 year [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
- Death or re-infarction (MI) at 30 days
- Death at 30 days and 365 days
- Re-infarction (MI) at 30 days
- IDR at 30 days
- Death, re-infarction (MI) or IDR at 30 days
- Death, re-infarction (MI) or non-CABG-related protocol major bleeding at 30 days
- Major bleeding at 30 days (protocol, TIMI and GUSTO)
- Minor bleeding at 30 days (protocol, TIMI, and GUSTO)
- Incidence of thrombocytopenia post index procedure and at 30 days
- Stent thrombosis (ARC definition) within 30 days
- Stroke at 30 days
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: bivalirudin, short peptide, IV||
0.75 mg/kg bolus followed by 1.75 mg/kg/hr infusion
Active Comparator: Heparin
•Heparin: IV bolus at a usual starting dose of 100 U/Kg weight (60 U/kg if GPI is used).
IV bolus at a usual starting dose of 100 U/Kg weight (60 U/kg if GPI is used).
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 patients 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 centres where PCI is not performed.
All patients are to receive treatment with aspirin (150-325 mg oral or 250-500 mg IV) followed by 75-100 mg/day for at least 1 year and a P2Y12 receptor blocker (such as clopidogrel 300 mg or 600 mg followed by 75 mg daily) as soon as logistically feasible.
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 and optional GPI) that at 30 days:
• Bivalirudin is superior to control at reducing a composite of death and non-CABG-related protocol major bleeding.
|Wilhelminenspital MA 6 - BA 19|
|Prague, Czech Republic|
|Cardiologic Hospital - Coronary Care Unit, University of Bordeaux|
|Kerckhoff Heart Center|
|Bad Nauheim, Germany|
|Sana Klinikum Lichtenberg - Oskar-Ziethen Krankenhaus|
|Ospedale S. Donato|
|Jagiellonian University Medical College,|
|Hospital General Universitario Gregorio Maranon|
|Kings College Hospital|
|London, United Kingdom|
|Study Chair:||Gabriel Steg, Prof||Executive Committee|
|Study Chair:||Christian Hamm, BSc, MD, PhD||International Steering Committee|