This study is part of the RHU INNOV-CKD, winner of the 2019 call for projects. Its aim is to develop two biomarker assays to assess the thrombotic and haemorrhagic risks in patients with stage 3A or more severe chronic kidney disease (CKD) treated with percutaneous coronary intervention (PCI) and antiplatelet therapy following an acute coronary syndrome (ACS). We believe that these tests will help to adapt antiplatelet therapy on an individual basis (in terms of intensity and duration of treatment) and thus reduce the risk of thrombotic and haemorrhagic events in this particularly fragile population. The first biomarker corresponds to an intra-platelet molecule, Rap1b in its active form (known as aRap1b). The second is the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), which reflects endothelial dysfunction. An automated method for measuring these biomarkers will be developed in partnership with the D.Stago and BioCytex industries during the course of the project.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
850
12-24 hours after P2Y12 ADP receptor loading dose (LD)
1 month after Percutaneous Coronary Intervention (PCI)
Assistance Publique Hopitaux de Marseille
Marseille, France
RECRUITINGassessing the predictive value of high aRap1b expression
after antiplatelet loading dose in the occurrence of MACE
Time frame: 12 months
High Rap1b-GTP expression
after antiplatelet loading dose in the occurrence of MACE
Time frame: 1 month
High Rap1b-GTP expression
after antiplatelet loading dose in the occurrence of MACE
Time frame: 6 months
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Time frame: 1 month
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Time frame: 6 months
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Time frame: 12 months
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of MACE
Time frame: 1 month
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of MACE
Time frame: 6 months
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of MACE
Time frame: 12 months
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Time frame: 12 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of MACE
Time frame: 1 month
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of MACE
Time frame: 6 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of MACE
Time frame: 12 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of bleeding
Time frame: 6 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of bleeding
Time frame: 12 months
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