Evaluation of the Effectiveness of Platelet-based and Microvesicle-based Assays to Predict Thrombotic and Bleeding Risk in Chronic Kidney Disease Patients With Acute Coronary Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAssistance Publique Hopitaux De Marseille

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Blood samples

    Biological/Vaccine

    12-24 hours after P2Y12 ADP receptor loading dose (LD)

  • Blood samples

    Biological/Vaccine

    1 month after Percutaneous Coronary Intervention (PCI)

Treatment groups

850 Participants
are divided into 1 treatment group
Group A: CKD patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

assessing the predictive value of high aRap1b expression

after antiplatelet loading dose in the occurrence of MACE

Time frame
12 months

Secondary outcomes

1

High Rap1b-GTP expression

after antiplatelet loading dose in the occurrence of MACE

Time frame
1 month
2

High Rap1b-GTP expression

after antiplatelet loading dose in the occurrence of MACE

Time frame
6 months
3

High Rap1b-GTP expression

after antiplatelet loading dose and after PCI in the occurrence of bleeding events

Time frame
1 month
4

High Rap1b-GTP expression

after antiplatelet loading dose and after PCI in the occurrence of bleeding events

Time frame
6 months

Other outcomes

Sponsors and contacts

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