Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
- Conditions
- Myocardial Infarction
- Interventions
- Registration Number
- NCT00976092
- Lead Sponsor
- Deutsches Herzzentrum Muenchen
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 548
- Patients presenting within 24 hours from the onset of symptoms with STEMI
- Informed, written consent
- In women with childbearing potential a pregnancy test is obligatory.
- Age < 18 years
- Cardiogenic shock
- Active bleeding; bleeding diathesis; coagulopathy
- History of gastrointestinal or genitourinary bleeding <2 months
- Refusal to receive blood transfusion
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
- Suspected aortic dissection
- Heparin-induced thrombocytopenia
- Any previous stroke
- Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
- Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
- Use of coumadin derivatives within the last 7 days
- Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel
- Known malignancies or other comorbid conditions with life expectancy <1 year
- Known severe liver disease, severe renal failure
- Known allergy to the study medications
- Previous enrollment in this trial
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prasugrel + Bivalirudin Prasugrel 60 mg prasugrel plus bivalirudin Prasugrel + Bivalirudin Bivalirudin 60 mg prasugrel plus bivalirudin Clopidogrel + Heparin Clopidogrel clopidogrel as loading and heparin Clopidogrel + Heparin Heparin clopidogrel as loading and heparin
- Primary Outcome Measures
Name Time Method composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding 30 days
- Secondary Outcome Measures
Name Time Method all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis 30 days major bleeding complications 30 days cardiac death 30 days
Trial Locations
- Locations (3)
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Bavaria, Germany
Klinikum rechts der Isar, Technische Universitaet Muenchen
🇩🇪Munich, Bavaria, Germany
Herzzentrum der Segeberger Kliniken
🇩🇪Bad Segeberg, Germany