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

Launched by DEUTSCHES HERZZENTRUM MUENCHEN · Sep 11, 2009

Keywords

ClinConnect Summary

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 clopidogre...

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Eligibility 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