Patients presenting with a primary Percutaneous Coronary Intervention for a large acute myocardial infarction -ST elevation myocardial infarction (STEMI). MedDRA version: 17.0 Level: LLT Classification code 10000929 Term: Acute myocardial infarction, unspecified site, episode of care unspecified System Organ Class: 100000004849
Conditions
Sponsors
The Medicines Company Switzerland
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) <30 milliliter (mL)/minute (min) or dialysis dependent 10. Major surgery within the previous 30 days 11. Minor surgery/biopsy exclusions in the past 3 days 12. Upper gastrointestinal or genitourinary bleed 30 days prior to randomisation 13. Stroke or transient ischemic attack 30 days prior to randomisation 14. Administration of thrombolytics or GPI 72 h prior to PPCI 15. Administration of enoxaparin 8 h prior to PPCI 16. Administration of bivalirudin 12 h prior to PPCI 17. Administration of fondaparinux or other LMWH 24 h prior to PPCI 18. Known contraindications to aspirin or P2Y12 inhibitors 19. Known allergy that cannot be pre-medicated to iodinated contrast 20. Known contraindication to CMR 21. Women of child bearing potential (1) 22. Previous enrolment in this study 23. Treatment with other investigational drugs or devices within the 30 days preceding enrolment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached (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 objective of this study is to determine whether bivalirudin, compared to 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 (defined as 5 days +/- 36 h from randomisation) days after PPCI ;Secondary Objective: To determine whether bivalirudin, compared to Unfractionated Heparin (UFH), for primary Percutaneous Coronary Intervention (PPCI) in large ST segment elevation myocardial infarction (STEMI) can: • Improve 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]). • Improve LVEF by CMR at 90 days • Modulate markers of thrombin activity and cell injury after reperfusion;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
Italy, Netherlands
Contacts
Public ContactGlobal Health Science Center
The Medicines Company
Outcome results
None listed