European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial (EUROMAX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01087723
First received: March 12, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

To show that the early administration of bivalirudin improves 30 day outcomes when 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 performed.


Condition Intervention Phase
ST Segment Elevation Acute Coronary Syndrome
Drug: Bivalirudin
Drug: Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • A composite of death and non-CABG-related protocol major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death at 1 year [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
    • Death or re-infarction (MI) at 30 days
    • Death at 30 days and 365 days
    • Re-infarction (MI) at 30 days
    • IDR at 30 days
    • Death, re-infarction (MI) or IDR at 30 days
    • Death, re-infarction (MI) or non-CABG-related protocol major bleeding at 30 days
    • Major bleeding at 30 days (protocol, TIMI and GUSTO)
    • Minor bleeding at 30 days (protocol, TIMI, and GUSTO)
    • Incidence of thrombocytopenia post index procedure and at 30 days
    • Stent thrombosis (ARC definition) within 30 days
    • Stroke at 30 days


Enrollment: 2218
Study Start Date: February 2010
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bivalirudin, short peptide, IV Drug: Bivalirudin
0.75 mg/kg bolus followed by 1.75 mg/kg/hr infusion
Active Comparator: Heparin
•Heparin: IV bolus at a usual starting dose of 100 U/Kg weight (60 U/kg if GPI is used).
Drug: Heparin
IV bolus at a usual starting dose of 100 U/Kg weight (60 U/kg if GPI is used).

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 patients 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 centres where PCI is not performed.

All patients are to receive treatment with aspirin (150-325 mg oral or 250-500 mg IV) followed by 75-100 mg/day for at least 1 year and a P2Y12 receptor blocker (such as clopidogrel 300 mg or 600 mg followed by 75 mg daily) as soon as logistically feasible.

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 and optional GPI) that at 30 days:

• Bivalirudin is superior to control at reducing a composite of death and non-CABG-related protocol major bleeding.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087723

Locations
Austria
Wilhelminenspital MA 6 - BA 19
Wien, Austria
Czech Republic
Cardiocentre Vinohrady
Prague, Czech Republic
Denmark
Rigshospitalet
Copenhagen, Denmark
France
Cardiologic Hospital - Coronary Care Unit, University of Bordeaux
Pessac, France
Germany
Kerckhoff Heart Center
Bad Nauheim, Germany
Sana Klinikum Lichtenberg - Oskar-Ziethen Krankenhaus
Berlin, Germany
Italy
Ospedale S. Donato
Arezzo, Italy
Netherlands
Isala Klinieken
Zwolle, Netherlands
Poland
Jagiellonian University Medical College,
Krakow, Poland
Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
United Kingdom
Kings College Hospital
London, United Kingdom
Sponsors and Collaborators
The Medicines Company
Investigators
Study Chair: Gabriel Steg, Prof Executive Committee
Study Chair: Christian Hamm, BSc, MD, PhD International Steering Committee
  More Information

No publications provided by The Medicines Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01087723     History of Changes
Other Study ID Numbers: TMC-BIV-08-03
Study First Received: March 12, 2010
Last Updated: October 18, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by The Medicines Company:
EUROMAX
STEMI
STE-ACS
UFH
bivalirudin
PCI
ambulance study
STE-MI patients

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Bivalirudin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014