DRUG
European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial
Status
Completed
Phase
Phase 3
Enrollment
2,198
Locations
145
Results
Posted
Publications
9
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Heparin
Timeline
From registration to results.
First posted
Mar 16, 2010
Study start
Mar 2010
Primary completion
Aug 2013
Study completion
Aug 2014
Results posted
Feb 12, 2016
Registry updated
Feb 12, 2016
Outcomes
What the study measures.
Primary outcomes
The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding
Time frame · Within 30 days
A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of \>4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of \>3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion.
Secondary outcomes
The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding
Time frame · Within 30 days
A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction \[MI\], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of \>4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of \>3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI.
The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)
Time frame · Within 30 days
Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of \>4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of \>3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia.
The Incidence of Death at 1 Year
Time frame · Within 1 Year
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time.
The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)
Time frame · Within 30 days
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of \>5 g/dL (or, when Hb was not available, an absolute drop in hematocrit \[Hct\] \>15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment.
The Incidence of Minor Bleeding: TIMI and GUSTO
Time frame · Within 30 days
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise.
The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])
Time frame · Within 30 days
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis.
The Incidence of Thrombocytopenia
Time frame · Within 30 days
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count \<100,000 cells/millimeter cubed (cells/mm\^3) in a participant with a baseline or pre-procedural platelet count \>100,000 cells/mm\^3.
The Incidence of Stroke
Time frame · Within 30 days
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: The decision to randomize participants was made by a qualified physician or paramedic who was present at the time. Participants were included in the study if they presented either via ambulance or to a center where PCI was not performed and met all of the following criteria: 1. Provided written informed consent before initiation of any study related procedures. Participants randomized in the ambulance may initially have signed an abridged version. 2. Aged ≥18 years at the time of randomization. 3. Had a presumed diagnosis of STE-ACS with onset of symptoms of \>20 minutes and \<12 hours with one or more of the following: * ST segment elevation of ≥1 millimeters (mm) in ≥2 contiguous leads * Presumably new left bundle branch block * An infero-lateral myocardial infarction with ST segment depression of ≥1 mm in ≥2 of leads V1-3 with a positive terminal T wave 4. All participants would proceed with emergent angiography and primary PCI if indicated \<2 hours after first medical contact Exclusion Criteria: Participants were excluded from the study if any of the following exclusion criteria applied prior to randomization: 1. Any bleeding diathesis or severe hematological disease or history of intra-cerebral mass, aneurysm, arterio-venous malformation, hemorrhagic stroke, intra-cranial hemorrhage, or gastrointestinal or genitourinary bleeding within the last 2 weeks. 2. Participants who had undergone recent surgery (including biopsy) within the last 2 weeks. 3. Participants who were on warfarin (not applicable if International Normalized Ratio known to be \<1.5). 4. Participants who had received UFH, LMWH, or bivalirudin immediately before randomization. 5. Thrombolytic therapy within the last 48 hours. 6. Absolute contra-indications or allergy that could not be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel. 7. Contraindications to angiography, including but not limited to severe peripheral vascular disease. 8. If it was known, pregnant or nursing mothers. Women of child-bearing age were asked if they were pregnant or thought that they may be pregnant. 9. If it is known, a creatinine clearance \<30 milliliter/minute or dialysis dependent. 10. Previous enrolment in this study. 11. Treatment with other investigational drugs or devices within the 30 days preceding randomization or planned use of other investigational drugs or devices in this trial. 12. Participants may not have been enrolled if the duration of randomized investigational medicinal product anti-thrombin infusion was likely to be \<30 minutes from the time of onset to the commencement of angiography. 13. Participants may not have been enrolled within a primary PCI-capable hospital (unless at the time of randomization, the catheter laboratory was not available, and the participant required transfer to another primary PCI capable hospital). 14. Estimated body weight of \>120 kg
Study locations
145 registered sites.
Austria · Czechia · Denmark · France · Germany · Italy · Netherlands · Poland · Slovenia. Showing up to 24 locations stored in the fast local snapshot.
Hanusch Krankenhaus
Vienna, Austria
Magistratsabeilung 70, Wiener
Vienna, Austria
Universitats-Klinik Fur
Vienna, Austria
Wilhelminenspital MA 6 - BA 19
Vienna, Austria
Zdravotnicka Zachranna Sluzba
České Budějovice, Czechia
Aarhus Universitetshospital
Aarhus, Denmark
Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Akutlaegebil Nordsjaelland
Hillerød, Denmark
Laegeambulancen Odense
Odense, Denmark
Odense Universitets Hospital
Odense, Denmark
Hopital Europeen Paris La Roseraie
Aubervilliers, France
Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques
Bobigny, France
Chu De Bordeaux - Hopital Pellegrin
Bordeaux, France
Centre Hospitalier Bourg En Bresse
Bourg-en-Bresse, France
Clinique Convert
Bourg-en-Bresse, France
Ch Jacques Coeur
Bourges, France
Centre Hospitalier Universitaire De Caen
Caen, France
Hopital Prive Saint Martin
Caen, France
Service De Cardiologie
Cedex, France
Ch Chateauroux
Châteauroux, France
Chu Clermont-Ferrand, Hopital
Clermont-Ferrand, France
Samu-Smur Chu Clermont-Ferrand
Clermont-Ferrand, France
Publications
Results and literature.
Related trials
More studies on Bivalirudin.
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Duke University · Coronavirus Infection (COVID-19) · Pulmonary Arterial Hypertension
Not applicable
Recruiting
5,000
2026-07
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Xiaotong Hou · Extracorporeal Membrane Oxygenation Complication
Not applicable
Recruiting
154
2026-04
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis
Xinqiao Hospital of Chongqing · Acute Ischemic Stroke
Phase 3
Not yet recruiting
786
2026-01
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.