Patients presenting with a primary Percutaneous Coronary Intervention for a large acute myocardial infarction -ST elevation myocardial infarction (STEMI). MedDRA version: 18.1 Level: LLT Classification code 10000929 Term: Acute myocardial infarction, unspecified site, episode of care unspecified System Organ Class: 100000004849
Conditions
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: 1.= 18 years 2.Experience ischemic symptoms of >20 min and /=21) 6. Are candidates for PPCI 7. Administration of an initial dose of 150-325 mg orally (or 250-500 mg IV) and a loading dose of any approved P2Y12 inhibitor 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following exclusion criteria apply prior to enrollment: 1. Contraindication or known hypersensitivity to bivalirudin or UFH 2. Refusal to receive blood transfusion/products 3. Subjects requiring staged coronary artery bypass graft (CABG) procedure within the first 90 days 4. Known international normalized ratio (INR) = 2 or known prothrombin time (PT) >1.5 times upper limit of normal on the day of the index PPCI, or known history of bleeding diathesis 5. Therapy with vitamin K antagonists (VKA), within 72 h of PPCI 6. Therapy with dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agents within 48 h of PPCI 7. History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass, aneurysm, arteriovenous malformation, or recent head injury (within the last 5 days) 8. Subjects with previous history of Q-wave MI 9. Known glomerular filtration rate (GFR) 150 kg (1) Child bearing potential is defined as: A female patient is considered to have childbearing potential unless she meets at least one of the following criteria: • Age =50 years and naturally amenorrhoeic for = 1 year* • Premature ovarian failure confirmed by a specialist gynaecologist • Previous bilateral salpingo-oophorectomy, or hysterectomy. • XY genotype, Turner’s syndrome, uterine agenesis. *Amenorrhoea following cancer therapy does not rule out childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine whether treatment with bivalirudin, compared with treatment with Unfractionated Heparin (UFH), for primary Percutaneous Coronary Intervention (PPCI) in large ST- segment elevation myocardial infarction (STEMI) can reduce infarct size assessed by cardiac magnetic resonance (CMR) at 5 days (defined as 5 days +/- 36 h from randomisation) after PPCI ;Secondary Objective: The secondary objectives of this study are to determine the effects of bivalirudin compared with UFH treatment for PPCI in STEMI on: • Other CMR derived parameters of myocardial recovery 5 days after PPCI (i.e. left ventricular ejection fraction [LVEF], myocardial salvage index [MSI] and micro-vascular obstruction [MVO]). • LVEF as assessed by CMR at 90 days • Markers of thrombin activity and cell injury after reperfusion • Coronary flow and microcirculation at end of PCI • Survival at 90 days ;Primary end point(s): The primary end point of the trial is infarct size assessed by contrast enhanced cardiac magnetic resonance imaging (CMR) at 5 days post-PPCI.;Timepoint(s) of evaluation of this end point: primary endpoint: 5 days post-PPCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of this trial are: • CMR micro-vascular obstruction (MVO) assessment at 5 days • CMR myocardial salvage index (MSI) at 5 days • CMR assessment of LVEF at 5 days • CMR assessment of LVEF at 90 days • TIMI flow and Myocardial Blush Grade (MBG) at end of PPCI • In-hospital net adverse clinical events (NACE) at 5 days or discharge, whichever comes first (death, re-infarction, ischaemia driven revascularisation [IDR], and Bleeding Academic Research Consortium [BARC] =3 bleeding) • Death at 90 days;Timepoint(s) of evaluation of this end point: • CMR micro-vascular obstruction (MVO) assessment - 5 days • CMR myocardial salvage index (MSI) - 5 days • CMR assessment of LVEF - 5 days • CMR assessment of LVEF - 90 days • TIMI flow and Myocardial Blush Grade (MBG) - end of PPCI • In-hospital net adverse clinical events (NACE) - 5 days or discharge, whichever comes first (death, re-infarction, ischaemia driven revascularisation [IDR], and Bleeding Academic Research Consortium [BARC] =3 bleeding) • Death - 90 days | — |
Countries
Netherlands
Contacts
Public ContactGlobal Health Science Center
The Medicines Company
Outcome results
None listed