Phase 3
N=2,198
European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01087723 ↗Enrolled (actual)
2,198
Serious AEs
12.5%
Results posted
Feb 2016
Primary outcome: Primary: The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding — 5.1; 8.5 percentage of participants — p=0.0014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bivalirudin (Drug); Heparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Medicines Company
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding |
5.1; 8.5 | 0.0014 sig |
| SECONDARY The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding |
6.6; 9.2 | — |
| SECONDARY The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) |
2.9; 3.1; 1.7; 0.9; 2.6; 6.0 | — |
| SECONDARY The Incidence of Death at 1 Year |
5.4; 5.3 | — |
| SECONDARY The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO) |
1.3; 2.1; 1.3; 2.3 | — |
| SECONDARY The Incidence of Minor Bleeding: TIMI and GUSTO |
6.5; 11.2; 6.5; 11.0 | — |
| SECONDARY The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition]) |
1.6; 0.5 | — |
| SECONDARY The Incidence of Thrombocytopenia |
0.7; 1.4 | — |
| SECONDARY The Incidence of Stroke |
0.6; 1.0 | — |
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.
Eligibility Criteria
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:
- Provided written informed consent before initiation of any study related procedures. Participants randomized in the ambulance may initially have signed an abridged version.
- Aged ≥18 years at the time of randomization.
- Had a presumed diagnosis of STE-ACS with onset of symptoms of >20 minutes and 120 kg
Data sourced from ClinicalTrials.gov (NCT01087723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.