Status:
UNKNOWN
Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheter...
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
548 Patients enrolled
Trial Details
Trial ID
NCT00976092
Start Date
September 1 2009
End Date
February 1 2015
Last Update
January 7 2014
Active Locations (3)
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1
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, 80636
2
Klinikum rechts der Isar, Technische Universitaet Muenchen
Munich, Bavaria, Germany, 81674
3
Herzzentrum der Segeberger Kliniken
Bad Segeberg, Germany, 23795