About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Man or woman ≥18 years old and <90
If the subject is a woman, she must be on contraception or menopausal.
ST-segment elevation ≥1 mm in two or more contiguous ECG leads
New or presumably new left bundle branch block (LBBB).
Disqualifiers
- Minors, pregnant or breast-feeding women;
Subject under chronic anticoagulant
Subject with thrombolytic therapy during the preceding 24 hours;
Subject with bleeding diathesis;
Trial design
Single group
Treatments tested in this trial
Blood samples
Biological/Vaccine12-24 hours after P2Y12 ADP receptor loading dose (LD)
Blood samples
Biological/Vaccine1 month after Percutaneous Coronary Intervention (PCI)
Treatment groups
Trial outcomes
Primary outcomes
assessing the predictive value of high aRap1b expression
after antiplatelet loading dose in the occurrence of MACE
Secondary outcomes
High Rap1b-GTP expression
after antiplatelet loading dose in the occurrence of MACE
High Rap1b-GTP expression
after antiplatelet loading dose in the occurrence of MACE
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Sponsors and contacts
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