This study investigates whether a platelet function testing guided approach with a short-term (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).
Patients suffering of heart attack have highly activated blood platelets. During and after invasive treatment of blocked coronary vessels (percutaneous coronary intervention = PCI) a potent platelet inhibition is needed to reduce the risk of thrombotic complications which is particularly high within the first week after PCI. On the other hand, the use of potent platelet inhibitors such as prasugrel is associated with higher bleeding risk particularly when used at long-term. A combination of a potent antiplatelet drug (prasugrel) within the first week with a less potent antiplatelet drug (clopidogrel) thereafter might lead to a higher net clinical benefit - means less bleeding and thrombotic complications. This hypothesis is being investigated in the current trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,600
see Arm description
see arm description
Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria
Time frame: 12 months
bleeding events BARC class ≥2
Time frame: 12 months
stent thrombosis
Time frame: 12 months
all-cause death
Time frame: 12 months
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Medizin-Universität Graz, Univ. Klinik für Innere Medizin
Graz, Austria
Wilhelminenspital Wien, 3. Medizinische Abteilung
Vienna, Austria
Klinikum Augsburg, Department of Cardiology
Augsburg, Germany
Heart Center Bad Krozingen
Bad Krozingen, Germany
Asklepios Stadtklinik Bad Tölz, Internal Medicine
Bad Tölz, Germany
St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology
Bochum, Germany
Herzzentrum der Universität zu Köln
Cologne, Germany
Universitätsklinikum Frankfurt, Department of Cardiology
Frankfurt, Germany
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
Füssen, Germany
Heart Center at the University Medical Center Goettingen
Göttingen, Germany
...and 23 more locations