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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05765630
Other study ID # RCAPHM20_0328
Secondary ID 2020-A01264-35_
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2023
Est. completion date March 2024

Study information

Verified date March 2023
Source Assistance Publique Hopitaux De Marseille
Contact Stephane BURTEY, Pr.
Phone +33(0)634603257
Email stephane.burtey@univ-amu.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this PROJECT is to develop two biomarkers to assess the thrombotic and hemorrhagic risk of patients with chronic renal failure (CKD) treated with antiplatelet drugs following the occurrence of an acute coronary syndrome (ACS). These biomarkers will help to adapt antiplatelet therapy on an individual basis (intensity, duration of antiplatelet treatment) and thus reduce the risk of thrombotic and hemorrhagic events in this particularly fragile population. The methods for measuring these two highly innovative biomarkers are currently being developed. The first biomarker corresponds to the measurement of an intraplatelet molecule, Rap1b in its active form (aRap1b). The second biomarker is the measurement of the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), a reflection of endothelial dysfunction. An automated method for biomarker measurement will be developed in partnership with the industrial partners Stago and BioCytex during the project.


Recruitment information / eligibility

Status Recruiting
Enrollment 115
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Healthy subjects (group 1): DFG>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security. - Antiplatelet agents-naïve CKD patients (group 2): DFG<30 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security. - CKD patients receiving antiplatelet agents (group 3): DFG<30 ml/mn/1.73m2 in CKD-EPi, receiving antiplatelet agents, Age 18-85 years old, consent required, Affiliated with social security. - Patients with constitutional platelet dysfunction (group 4): DFG>70 ml/min/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Constitutional haemorrhagic syndrome - Coronary patients (group 5): DFG>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Acute Coronary Syndrome in the previous month requiring AAP. Exclusion Criteria: - For all the groups : subjects refusing to participate in the study, pregnant or breastfeeding women, minors (except for special consent), adults subject to a legal protection measure or unable to express their consent (persons under guardianship or curatorship), persons deprived of their rights of liberty by judicial or administrative decision (persons in a situation of social fragility), persons at the end of life.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BLOOD SAMPLES
BLOOD SAMPLES

Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary aRap1b assay reproducibility intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of aRap1b-GTP for subjects from groups 1, 2, 3, and 5. 1 year
Secondary Reproducibility of pat EMV intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of microvesicle derived functional assays for subjects from groups 1, 2, 3, and 5. 1 year
Secondary Repeatability Coefficient of variation will be determined for different levels of concentration of the analytes (aRap1b resting and activates states and pat EMV) 1 year
Secondary Analytical specificity Best threshold values between samples containing the analyte (aRap1B) compared to negative samples which do not contain the analyte. 1 year
Secondary Range of values in each group Mean, standard deviation, median, interquartile range 1 year
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