Comparing the effectiveness of the study drug bivalirudin to the standard of care in patients suffering from heart

Conditions: Patients presenting with ST-Segment Elevation Acute Coronary Syndrome (STE-ACS) planned for a primary Percutaneous Coronary Intervention (PCI) management strategy
MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 14.1Level: LLTClassification code 10041894Term: ST segment elevationSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2008-007290-20-NL

Lead Sponsor: The Medicines Company UK Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3680

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 1104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2576

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Glycoprotein IIb/IIIa Inhibitor [GPI]) that at 30 days:<br>• Bivalirudin is superior to control at reducing a composite of death, re-infarction (Myocardial Infarction [MI]) or non-Coronary Artery Bypass Grafts (CABG)-related protocol major bleeding.<br>;Secondary Objective: There is no secondary objective.;Primary end point(s): • A composite of death, and non-CABG-related protocol major bleeding;Timepoint(s) of evaluation of this end point: The primary endpoint of this trial at 30 days is:<br>

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) within 30 days<br>• Stroke at 30 daysARC definition) within at 30 days<br>• Stroke at 30 days;Timepoint(s) of evaluation of this end point: 30 days and 365 days<br>

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