Evaluation of the Effectiveness of Platelet-based and Microvesicle-based Assays to Predict
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 f
| Condition(s) | Chronic Kidney Disease stage3 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Man or woman ≥18 years old and \<90 * If the subject is a woman, she must be on contraception or menopausal. * Non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: (1) symptoms of myocardial ischemia, (2) electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or (3) an elevated cardiac troponin value (above the upper limit of normal) 56 or ST segment elevation ACS scheduled for primary PCI defined 57 as a history of chest discomfort or ischemic symptoms of \>20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG: 1. ST-segment elevation ≥1 mm in two or more contig |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
| Locations | Marseille, France |
| Start date | 2023-10-12 |
| NCT ID | NCT06026436 |
| Official listing | https://clinicaltrials.gov/study/NCT06026436 |