This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
364
Unnamed facility
Graz, Austria
Unnamed facility
Linz, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Aalst, Belgium
Unnamed facility
Charleroi, Belgium
Unnamed facility
Genk, Belgium
Unnamed facility
Jette, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Yvoir, Belgium
Unnamed facility
Brno, Czechia
...and 29 more locations
Incidence and severity of bleeding classified by the following criteria: TIMI major bleeding events, TIMI minor bleeding events, bleeding events requiring medical attention, defined as TIMI minimal bleeding events
Time frame: 30 days
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