Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

• Status: Unknown status
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheterization and coronary intervention.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Bivalirudin; Calcium heparin; Clopidogrel; Heparin; Hirudins; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

1. Patients presenting within 24 hours from the onset of symptoms with STEMI

2. Informed, written consent

3. In women with childbearing potential a pregnancy test is obligatory.

Exclusion Criteria:

1. Age < 18 years

2. Cardiogenic shock

3. Active bleeding; bleeding diathesis; coagulopathy

4. History of gastrointestinal or genitourinary bleeding <2 months

5. Refusal to receive blood transfusion

6. Major surgery in the last 6 weeks

7. History of intracranial bleeding or structural abnormalities

8. Suspected aortic dissection

9. Heparin-induced thrombocytopenia

10. Any previous stroke

11. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI

12. Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l

13. Use of coumadin derivatives within the last 7 days

14. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel

15. Known malignancies or other comorbid conditions with life expectancy <1 year

16. Known severe liver disease, severe renal failure

17. Known allergy to the study medications

18. Previous enrollment in this trial

19. Pregnancy