Patients presenting with ST-Segment Elevation Acute Coronary Syndrome (STE-ACS) planned for a primary Percutaneous Coronary Intervention (PCI) management strategy MedDRA version: 14.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: LLT Classification code 10041894 Term: ST segment elevation System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Angiox
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: BIVALIRUDIN
CAS Number: 128270-60-0
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
The Medicines Company UK Ltd.
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 880
Exclusion criteria
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 120 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • Bivalirudin is superior to control at reducing a composite of death and non-Coronary Artery Bypass Grafts (CABG)-related protocol major bleeding. ;Secondary Objective: ;Primary end point(s): The primary endpoint is a composite of death, and non-CABG-related protocol major bleeding;Timepoint(s) of evaluation of this end point: 30 days (±5 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 at 30 days • Stroke at 30 days;Timepoint(s) of evaluation of this end point: 30 days and 365 days | — |
Countries
Austria, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Slovenia, Spain
Contacts
Public ContactGlobal Health Science Center
The Medicines Company
Outcome results
None listed