NCT01087723

European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,198 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 milligrams/day (mg/day) 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 IIb/IIIa 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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Bivalirudin
DRUG	Heparin

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-08-01
• Completion: 2014-08-01
• First posted: 2010-03-16
• Last updated: 2016-02-12
• Results posted: 2016-02-12

Locations

145 sites across 9 countries: Austria, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Slovenia