Myocardial Infarction
Conditions
Keywords
myocardial infarction, clopidogrel, prasugrel, bivalirudin, primary PCI
Brief 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.
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.
Interventions
DRUGPrasugrel
60 mg prasugrel as loading dose prior to PPCI
DRUGBivalirudin
IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
DRUGClopidogrel
600 mg clopidogrel as loading dose before PPCI
DRUGHeparin
i.v. bolus of 70-100 IU/kg body weight
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis | 30 days |
| major bleeding complications | 30 days |
| cardiac death | 30 days |
Countries
Germany
Outcome results
None listed