European Ambulance Acute Coronary Syndrome Angiox Trial: EUROMAX

• Conditions: Patients presenting with ST-segment elevation acute coronary syndrome (STE-ACS) planned for primary percutaneous coronary itervention (PCI) management strategy; MedDRA version: 15.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 15.0Level: LLTClassification code 10041894Term: ST segment elevationSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-007290-20-PL
• Lead Sponsor: The Medicines Company UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

1.Patients randomised in the ambulance may initially sign an abridged version.
2. Be aged =18 years at the time of randomisation.
3. Have a presumed diagnosis of a STE-ACS with onset of symptoms of >20 minutes and
<12 hours with one or more of the following:
• ST segment elevation of =1 mm in =2 contiguous leads
• Presumably new left bundle branch block
• An infero-lateral MI with ST segment depression of =1 mm in =2 of leads V1-3)
with a positive terminal T wave
4. All patients must be scheduled for angiography +/- PCI (if indicated) <2 hours after first medical contact
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1100

Exclusion Criteria

1. Any bleeding diathesis or severe haematological disease or history of
intra-cerebral mass, aneurysm, arterio-venous malformation, haemorrhagic stroke, intra-cranial haemorrhage or gastrointestinal or genitourinary bleeding within the last 2-weeks.
2. Patients who have undergone recent surgery (including biopsy) within the last two weeks.
3. Patients on warfarin (not applicable if INR known to be <1.5).
4. Patients who have received UFH, LMWH or bivalirudin immediately before randomisation.
5. Thrombolytic therapy within the last 48 hours.
Absolute contraindications or allergy that cannot 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 is known pregnant or nursing mothers. Women of child-bearing age will be asked if
they are pregnant or think that they may be pregnant.
9. If it is known a creatinine clearance <30 mL/min or dialysis dependent.
10. Previous enrolment in this study.
11. Treatment with other investigational drugs or devices within the 30 days preceding
randomisation or planned use of other investigational drugs or devices in this trial.
12. Patients may not be enrolled if the duration of randomised investigational medicinal
product (IMP) anti-thrombin infusion is likely to be less than 30 minutes from the time of
onset to the commencement of angiography.
13. Patients may not be enrolled within a primary PCI capable hospital (unless at the time of randomisation the catheter laboratory is not
available and the patient requires transfer to
another primary PCI capable hospital).
14. Estimated body weight of >120 kg.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show that the early administration of bivalirudin improves 30 day outcomes when<br>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<br>performed.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of this trial at 30 days is:<br>• A composite of death or non-CABG-related protocol major bleeding<br>;Timepoint(s) of evaluation of this end point: 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Death or re-infarction (MI) at 30 days<br>• Death at 30 days and 365 days<br>• Re-infarction (MI) at 30 days<br>• IDR at 30 days<br>• Death, re-infarction (MI) or IDR at 30 days<br>• Death, re-infarction (MI) or non-CABG-related protocol major bleeding at 30 days<br>• Major bleeding at 30 days (protocol, TIMI and GUSTO)<br>• Minor bleeding at 30 days (protocol, TIMI, and GUSTO)<br>• Incidence of thrombocytopenia post index procedure and at 30 days<br>• Stent thrombosis (ARC definition) at 30 days<br>• Stroke at 30 days;Timepoint(s) of evaluation of this end point: 30 and 365 days