Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.
Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
795
see arm description
see arm description
Universitäts-Herzzentrum Freiburg, Bad Krozingen
Freiburg im Breisgau, Bad Krozingen, Germany
Munich University Hospital
Munich, Bavaria, Germany
Deutsches Herzzentrum Muenchen
Munich, Germany
Klinikum Bogenhausen
Munich, Germany
Heart Center Balatonfüred and Heart and Vascular Center
Balatonfüred, Hungary
Combined ischemic events
Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke
Time frame: 30 days
Bleeding
Academic Research Consortium ≥2 bleeding and TIMI classification
Time frame: 30 days
Peri-PCI MI Type 4a
according to Third Universal Definition of MI
Time frame: 30 days
All-cause death
mortality
Time frame: 30 days
Any myocardial infarction
according to SASSICAIA protocol definition
Time frame: 30 days
Stent thrombosis
according to Academic Research Consortium criteria
Time frame: 30 days
Urgent vessel revascularization
revascularization related to symptoms
Time frame: 30 days
cerebro-vascular events
stroke and TIA
Time frame: 30 days
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