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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 (INNOV CKD 1)

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ClinicalTrials.gov Identifier: NCT06026436
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : October 27, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief 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 (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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease stage3 Biological: Blood samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : October 12, 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: CKD patients Biological: Blood samples
12-24 hours after P2Y12 ADP receptor loading dose (LD)

Biological: Blood samples
1 month after Percutaneous Coronary Intervention (PCI)


Outcome Measures
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Primary Outcome Measures :
  1. assessing the predictive value of high aRap1b expression [ Time Frame: 12 months ]
    after antiplatelet loading dose in the occurrence of MACE


Secondary Outcome Measures :
  1. High Rap1b-GTP expression [ Time Frame: 1 month ]
    after antiplatelet loading dose in the occurrence of MACE

  2. High Rap1b-GTP expression [ Time Frame: 6 months ]
    after antiplatelet loading dose in the occurrence of MACE

  3. High Rap1b-GTP expression [ Time Frame: 1 month ]
    after antiplatelet loading dose and after PCI in the occurrence of bleeding events

  4. High Rap1b-GTP expression [ Time Frame: 6 months ]
    after antiplatelet loading dose and after PCI in the occurrence of bleeding events

  5. High Rap1b-GTP expression [ Time Frame: 12 months ]
    after antiplatelet loading dose and after PCI in the occurrence of bleeding events

  6. Low Rap1b-GTP expression [ Time Frame: 1 month ]
    after antiplatelet loading dose and after PCI in the occurrence of MACE

  7. Low Rap1b-GTP expression [ Time Frame: 6 months ]
    after antiplatelet loading dose and after PCI in the occurrence of MACE

  8. Low Rap1b-GTP expression [ Time Frame: 12 months ]
    after antiplatelet loading dose and after PCI in the occurrence of MACE

  9. Low Rap1b-GTP expression [ Time Frame: 12 months ]
    after antiplatelet loading dose and after PCI in the occurrence of bleeding events

  10. High MV procoagulant and profibrinolytic expressions [ Time Frame: 1 month ]
    after antiplatelet loading dose and after PCI, in the occurrence of MACE

  11. High MV procoagulant and profibrinolytic expressions [ Time Frame: 6 months ]
    after antiplatelet loading dose and after PCI, in the occurrence of MACE

  12. High MV procoagulant and profibrinolytic expressions [ Time Frame: 12 months ]
    after antiplatelet loading dose and after PCI, in the occurrence of MACE

  13. High MV procoagulant and profibrinolytic expressions [ Time Frame: 6 months ]
    after antiplatelet loading dose and after PCI, in the occurrence of bleeding

  14. High MV procoagulant and profibrinolytic expressions [ Time Frame: 12 months ]
    after antiplatelet loading dose and after PCI, in the occurrence of bleeding


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 contiguous ECG leads
    2. New or presumably new left bundle branch block (LBBB).
    3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction
  • Subject intended for an invasive strategy if NSTE-ACS or primary PCI if STE-ACS according to guidelines (appendix X)
  • Subject with CKD stage 3A or higher (estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m2 according to the CKD-EPI formula
  • Because of the documented biological variability of eGRF levels, patients with a eGRF < 78 ml/min/1.73 m2 can be included in this study, based on previous blood test results and on the investigator's decision. The DFG level of 78 ml/min/1.73 m2 correspond to an increase of 30 % of a DFG of 60 ml/min/1.73 m2. Indeed, the literature estimated a DFG levels variability of 30 % 58-61.
  • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital.
  • Subject affiliated to or beneficiary of a social security system.
  • Subject having signed written informed consent.

Exclusion Criteria:

  • - Minors, pregnant or breast-feeding women;
  • Subject under chronic anticoagulant
  • Subject with thrombolytic therapy during the preceding 24 hours;
  • Subject with bleeding diathesis;
  • Subject not agreeing to participate.
  • Subject with contraindication to clopidogrel, ticagrelor or to another anti platelet agent.
  • Severe hepatic failure
  • Ischemic Stroke within one month or a history of hemorrhagic stroke
  • Platelet count<100 000
  • Major surgery or trauma within 10 days
  • Life expectancy <1 year
  • Known significant bleeding risk according to the physician judgment
  • Adults subject to a legal protection measure or unable to express their consent (persons under guardianship, curatorship or safeguard of justice)
  • Persons deprived of their rights of liberty by judicial or administrative decision (persons in a situation of social fragility)
  • Progressive cancer
  • Systemic autoimmune disease
  • Chronic viral or bacterial infections
  • Diabetes requiring insulin therapy
  • Constitutional haemorrhagic syndrome
  • Organ transplantation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06026436


Contacts
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Contact: LAURENT BONELLO 0491968858 laurent.bonello@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: GIULIANI ALEXANDRA       promotion.interne@ap-hm.fr   
Principal Investigator: BONELLO LAURENT         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: FRANCOIS CREMIEUX Assistance Publique Hopitaux Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT06026436    
Other Study ID Numbers: RCAPHM23_0073 - INNOV-CKD1
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: October 27, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
 Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases