The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo in patients with stable coronary artery disease undergoing PCI.
Revacept is a protein that is made up of an Fc fragment ("fragment crystallisable") fused to the GPVI receptor (the endogenous platelet collagen receptor). Consequently, Revacept binds to its ligand (collagen) on atherosclerotic plaques preventing circulating thrombocytes from binding to collagen exposed by the injured plaque. All this is achieved without affecting systemic hemostasis. Thus, blocking of GPVI-dependent pathways by interfering with vascular collagen sites is commonly seen as an attractive target for an anti-platelet therapy of atherosclerotic diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
334
single dose, intravenous application of 80 mg Revacept
single dose, intravenous application of 180 mg Revacept
single dose, intravenous application of Placebo solution
Deutsches Herzzentrum München
Munich, Bavaria, Germany
Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
Charité - Universitätsmedizin Berlin, Campus Virchow
Berlin, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie
Primary endpoint-composite endpoint of death and myocardial injury
A composite endpoint of death or myocardial injury (defined as increase in cardiac biomarker - high sensitivity cardiac troponin T of at least 5 times the upper limit of norm (ULN) within 48 hours from randomisation).
Time frame: within 48 hours from randomisation
All cause mortality
All cause mortality
Time frame: within 30 days after randomisation
Myocardial infarction
Myocardial infarction
Time frame: within 30 days after randomisation
PCI-related (type 4) myocardial infarction
PCI-related (type 4) myocardial infarction
Time frame: within 30 days after randomisation
Definite stent thrombosis
Definite stent thrombosis
Time frame: within 30 days after randomisation
Urgent coronary revascularization
Urgent coronary revascularization
Time frame: within 30 days after randomisation
Stroke
Stroke
Time frame: within 30 days after randomisation
Peak potprocedural high-sensitivity troponin T level
Peak potprocedural high-sensitivity troponin T level
Time frame: within 48 hours after randomisation
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Frankfurt am Main, Germany
Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I
Mainz, Germany
Klinikum der Universität München, Medizinische Klinik und Poliklinik I
Munich, Germany
Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik
Munich, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)
Time frame: within 30 days after randomisation