Bivalirudin Infusion for Ventricular Infarction Limitation

• Status: Terminated
• Trial end date: 2016-06-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Bivalirudin; Heparin; Hirudins

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