European Ambulance Acute Coronary Syndrome Angiox Trial: EUROMAX - EUROMAX

Phase 1

• Conditions: Patients presenting with ST-Segment Elevation Acute Coronary Syndrome (STE-ACS) planned for a primary Percutaneous Coronary Intervention (PCI) management strategy; MedDRA version: 12.0Level: LLTClassification code 10041894Term: ST segment elevation; MedDRA version: 12.0Level: LLTClassification code 10051592Term: Acute coronary syndrome

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-28
• Study Completion: 2014-08-01
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2198

Inclusion Criteria

The decision to randomise patients must be made by a qualified physician or paramedic who is present at the time.
Subjects may be included in the study if they present either via ambulance or to a centre where PCI is not performed and meet all of the following criteria:

1. Provide written informed consent before initiation of any study related procedures. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomisation:
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.
6. 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