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

Condition(s) targeted: Myocardial Infarction

Intervention: Prasugrel (Drug); Bivalirudin (Drug); Clopidogrel (Drug); Heparin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Deutsches Herzzentrum Muenchen

Official(s) and/or principal investigator(s):
Julinda Mehilli, MD, Principal Investigator, Affiliation: Deutsches Herzzentrum Muenchen
Adnan Kastrati, MD, Study Chair, Affiliation: Deutsches Herzzentrum Muenchen

Overall contact:
Julinda Mehilli, MD, Phone: +49-89-1218-, Ext: 1534, Email: mehilli@dhm.mhn.de

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.

Official title: Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding

Secondary outcome:

all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis

major bleeding complications

cardiac death

Detailed description: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional anticoagulation therapy prior or during intervention plays an important role in the short- and long-term outcomes after PPCI. Two separate studies have shown significant benefit against conventional therapy based on clopidogrel and heparin for two recently approved drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. In the HORIZONS-AMI trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcomes. However, during the first 24 hours after PPCI an increase in the stent thrombosis rate was observed with bivalirudin therapy. Prasugrel has been shown to be superior to clopidogrel in patients with acute coronary syndromes undergoing PCI. The benefit in reduction of ischemic complication was even greater in the subset of patients with STEMI without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. Expectedly, the synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing PPCI.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 or clopidogrel

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

Julinda Mehilli, MD, Phone: +49-89-1218-, Ext: 1534, Email: mehilli@dhm.mhn.de

Deutsches Herzzentrum Muenchen, Munich, Bavaria 80636, Germany; Recruiting
Julinda Mehilli, MD, Phone: +49-89-1218-, Ext: 1534, Email: mehilli@dhm.mhn.de
Barbara Merzljak, Phone: +49-89-1218-, Ext: 1534, Email: merzljak@dhm.mhn.de
Julinda Mehilli, MD, Principal Investigator

Klinikum Rechts der Isar, Technische Universitaet Muenchen, Munich, Bavaria 81674, Germany; Recruiting
Josef Dirschinger, MD, Phone: +49-89-4140-, Ext: 2948, Email: dirschinger@med1.med.tu-muenchen.de
Stefanie Schulz, MD, Phone: +49-89-1218-, Ext: 1534, Email: schulzs@dhm.mhn.de
Josef Dirschinger, MD, Principal Investigator

Starting date: September 2009
Ending date: July 2013
Last updated: September 11, 2009