Bivalirudin Infusion for Ventricular Infarction Limitation
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: PPCI; Bivalirudin; Heparin
Intervention description: PPCI for treatment of participants presenting with large STEMI.; Bivalirudin is an anticoagulant that binds thrombin in a bivalent and reversible fashion and directly inhibits it.; Heparin is an anticoagulant.
Intervention MeSH terms: Heparin; Bivalirudin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: The primary endpoint was evaluated by a core lab totally blinded to clinical information and the treatment groups.
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: STEMI, infarct size, CMR, bivalirudin

Summary:

      The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of
      the damage done to the heart muscle in participants who suffered a heart attack, compared to
      the comparator treatment (heparin).
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥18 years

          2. Experienced ischemic symptoms of >20 min and <12 h and had a diagnosis of STEMI with
             ST segment elevation of ≥1 mm in ≥2 contiguous precordial leads, or presumably new
             left bundle branch block

          3. Provided written informed consent or witnessed consent in countries and sites where
             such participant consenting is applicable, before initiation of any study-related
             procedures

          4. Had TIMI 0 or 1 flow in the IRA on initial angiogram

          5. Fulfilled angiographic criteria/score for a large infarction based on initial
             angiogram (Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease
             score of ≥21)

          6. Were candidates for PPCI

          7. Administration of an initial dose of 150 to 325 mg orally (or 250 to 500 mg IV) and a
             loading dose of any approved P2Y12 inhibitor

        Exclusion Criteria:

          1. Contraindication or known hypersensitivity to bivalirudin or UFH

          2. Refusal to receive blood transfusion/products

          3. Participants requiring staged coronary artery bypass graft procedure within the first
             90 days

          4. Known international normalized ratio ≥2 or known prothrombin time >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 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. Participants with previous history of Q-wave MI

          9. Known glomerular filtration rate (GFR) <30 milliliter/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 randomization

         13. Stroke or transient ischemic attack 30 days prior to randomization

         14. Administration of thrombolytics or glycoprotein IIb/IIIa inhibitor 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 low molecular weight heparin 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 (see below)

         22. Previous enrollment (participants are considered enrolled upon Randomization) in this
             study

         23. Treatment with other investigational drugs or devices within the 30 days preceding
             enrollment or planned use of other investigational drugs or devices before the primary
             endpoint of this study had been reached

         24. Participants with a body weight >150 kg

        Child bearing potential was defined as:

        A female participant was considered to have childbearing potential unless she met at least
        1 of the following criteria:

          -  Age ≥50 years and naturally amenorrheic for ≥1 year (amenorrhea following cancer
             therapy did not rule out childbearing potential)

          -  Premature ovarian failure confirmed by a specialist gynecologist

          -  Previous bilateral salpingo-oophorectomy or hysterectomy

          -  XY genotype, Turner's syndrome, uterine agenesis