Bivalirudin Infusion for Ventricular Infarction Limitatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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 <12 h and have a diagnosis of STEMI with ST segment elevation of =1 mm in =2 contiguous precordial leads, or presumably new left bundle branch block
3. Provide written informed consent, or witnessed consent in countries and sites where such patient consenting is applicable, before initiation of any study related procedures
4. Have TIMI 0 or 1 flow in the IRA on initial angiogram
5. Fulfill angiographic criteria/score for a large infarction based on initial angiogram (APPROACH score of >/=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

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
24. Patients with a body weight > 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