xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026436</url>
    </required_header>
    <id_info>
      <org_study_id>RCAPHM23_0073 - INNOV-CKD1</org_study_id>
      <nct_id>NCT06026436</nct_id>
    </id_info>
    <brief_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</brief_title>
    <acronym>INNOV CKD 1</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique Hopitaux De Marseille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique Hopitaux De Marseille</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is part of the RHU INNOV-CKD, winner of the 2019 call for projects. Its aim is to&#xD;
        develop two biomarker assays to assess the thrombotic and haemorrhagic risks in patients with&#xD;
        stage 3A or more severe chronic kidney disease (CKD) treated with percutaneous coronary&#xD;
        intervention (PCI) and antiplatelet therapy following an acute coronary syndrome (ACS). We&#xD;
        believe that these tests will help to adapt antiplatelet therapy on an individual basis (in&#xD;
        terms of intensity and duration of treatment) and thus reduce the risk of thrombotic and&#xD;
        haemorrhagic events in this particularly fragile population. The first biomarker corresponds&#xD;
        to an intra-platelet molecule, Rap1b in its active form (known as aRap1b). The second is the&#xD;
        pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), which reflects&#xD;
        endothelial dysfunction. An automated method for measuring these biomarkers will be developed&#xD;
        in partnership with the D.Stago and BioCytex industries during the course of the project.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>assessing the predictive value of high aRap1b expression</measure>
      <time_frame>12 months</time_frame>
      <description>after antiplatelet loading dose in the occurrence of MACE</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>High Rap1b-GTP expression</measure>
      <time_frame>1 month</time_frame>
      <description>after antiplatelet loading dose in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High Rap1b-GTP expression</measure>
      <time_frame>6 months</time_frame>
      <description>after antiplatelet loading dose in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High Rap1b-GTP expression</measure>
      <time_frame>1 month</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of bleeding events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High Rap1b-GTP expression</measure>
      <time_frame>6 months</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of bleeding events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High Rap1b-GTP expression</measure>
      <time_frame>12 months</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of bleeding events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low Rap1b-GTP expression</measure>
      <time_frame>1 month</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low Rap1b-GTP expression</measure>
      <time_frame>6 months</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low Rap1b-GTP expression</measure>
      <time_frame>12 months</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low Rap1b-GTP expression</measure>
      <time_frame>12 months</time_frame>
      <description>after antiplatelet loading dose and after PCI in the occurrence of bleeding events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High MV procoagulant and profibrinolytic expressions</measure>
      <time_frame>1 month</time_frame>
      <description>after antiplatelet loading dose and after PCI, in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High MV procoagulant and profibrinolytic expressions</measure>
      <time_frame>6 months</time_frame>
      <description>after antiplatelet loading dose and after PCI, in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High MV procoagulant and profibrinolytic expressions</measure>
      <time_frame>12 months</time_frame>
      <description>after antiplatelet loading dose and after PCI, in the occurrence of MACE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High MV procoagulant and profibrinolytic expressions</measure>
      <time_frame>6 months</time_frame>
      <description>after antiplatelet loading dose and after PCI, in the occurrence of bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High MV procoagulant and profibrinolytic expressions</measure>
      <time_frame>12 months</time_frame>
      <description>after antiplatelet loading dose and after PCI, in the occurrence of bleeding</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">850</enrollment>
    <condition>Chronic Kidney Disease stage3</condition>
    <arm_group>
      <arm_group_label>CKD patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Blood samples</intervention_name>
      <description>12-24 hours after P2Y12 ADP receptor loading dose (LD)</description>
      <arm_group_label>CKD patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Blood samples</intervention_name>
      <description>1 month after Percutaneous Coronary Intervention (PCI)</description>
      <arm_group_label>CKD patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Man or woman ≥18 years old and &lt;90&#xD;
  &#xD;
            -  If the subject is a woman, she must be on contraception or menopausal.&#xD;
  &#xD;
            -  Non-ST-segment elevation ACS defined by the presence of at least 2 of the following&#xD;
               criteria: (1) symptoms of myocardial ischemia, (2) electrocardiographic ST-segment&#xD;
               abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave&#xD;
               inversion in at least in 2 contiguous leads, or (3) an elevated cardiac troponin value&#xD;
               (above the upper limit of normal) 56 or ST segment elevation ACS scheduled for primary&#xD;
               PCI defined 57 as a history of chest discomfort or ischemic symptoms of &gt;20 minutes&#xD;
               duration at rest ≤14 days prior to entry into the study with one of the following&#xD;
               present on at least one ECG:&#xD;
  &#xD;
                 1. ST-segment elevation ≥1 mm in two or more contiguous ECG leads&#xD;
  &#xD;
                 2. New or presumably new left bundle branch block (LBBB).&#xD;
  &#xD;
                 3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with&#xD;
                    clinical history and evidence suggestive of true posterior infarction&#xD;
  &#xD;
            -  Subject intended for an invasive strategy if NSTE-ACS or primary PCI if STE-ACS&#xD;
               according to guidelines (appendix X)&#xD;
  &#xD;
            -  Subject with CKD stage 3A or higher (estimated glomerular filtration rate (eGFR) ≤ 60&#xD;
               ml/min/1.73 m2 according to the CKD-EPI formula&#xD;
  &#xD;
            -  Because of the documented biological variability of eGRF levels, patients with a eGRF&#xD;
               &lt; 78 ml/min/1.73 m2 can be included in this study, based on previous blood test&#xD;
               results and on the investigator's decision. The DFG level of 78 ml/min/1.73 m2&#xD;
               correspond to an increase of 30 % of a DFG of 60 ml/min/1.73 m2. Indeed, the&#xD;
               literature estimated a DFG levels variability of 30 % 58-61.&#xD;
  &#xD;
            -  Must be enrolled at a cardiac catheterization laboratory hospital or at a&#xD;
               hospital/ambulance service affiliated with a cardiac catheterization laboratory&#xD;
               hospital.&#xD;
  &#xD;
            -  Subject affiliated to or beneficiary of a social security system.&#xD;
  &#xD;
            -  Subject having signed written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  - Minors, pregnant or breast-feeding women;&#xD;
  &#xD;
            -  Subject under chronic anticoagulant&#xD;
  &#xD;
            -  Subject with thrombolytic therapy during the preceding 24 hours;&#xD;
  &#xD;
            -  Subject with bleeding diathesis;&#xD;
  &#xD;
            -  Subject not agreeing to participate.&#xD;
  &#xD;
            -  Subject with contraindication to clopidogrel, ticagrelor or to another anti platelet&#xD;
               agent.&#xD;
  &#xD;
            -  Severe hepatic failure&#xD;
  &#xD;
            -  Ischemic Stroke within one month or a history of hemorrhagic stroke&#xD;
  &#xD;
            -  Platelet count&lt;100 000&#xD;
  &#xD;
            -  Major surgery or trauma within 10 days&#xD;
  &#xD;
            -  Life expectancy &lt;1 year&#xD;
  &#xD;
            -  Known significant bleeding risk according to the physician judgment&#xD;
  &#xD;
            -  Adults subject to a legal protection measure or unable to express their consent&#xD;
               (persons under guardianship, curatorship or safeguard of justice)&#xD;
  &#xD;
            -  Persons deprived of their rights of liberty by judicial or administrative decision&#xD;
               (persons in a situation of social fragility)&#xD;
  &#xD;
            -  Progressive cancer&#xD;
  &#xD;
            -  Systemic autoimmune disease&#xD;
  &#xD;
            -  Chronic viral or bacterial infections&#xD;
  &#xD;
            -  Diabetes requiring insulin therapy&#xD;
  &#xD;
            -  Constitutional haemorrhagic syndrome&#xD;
  &#xD;
            -  Organ transplantation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>FRANCOIS CREMIEUX</last_name>
      <role>Study Director</role>
      <affiliation>Assistance Publique Hopitaux Marseille</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>LAURENT BONELLO</last_name>
      <phone>0491968858</phone>
      <email>laurent.bonello@ap-hm.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Acute Coronary Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026436
  org study id: RCAPHM23_0073 - INNOV-CKD1
  nct id: NCT06026436
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: assessing the predictive value of high aRap1b expression
  time frame: 12 months
  description: after antiplatelet loading dose in the occurrence of MACE
  measure: High Rap1b-GTP expression
  time frame: 1 month
  description: after antiplatelet loading dose in the occurrence of MACE
  measure: High Rap1b-GTP expression
  time frame: 6 months
  description: after antiplatelet loading dose in the occurrence of MACE
  measure: High Rap1b-GTP expression
  time frame: 1 month
  description: after antiplatelet loading dose and after PCI in the occurrence of bleeding events
  measure: High Rap1b-GTP expression
  time frame: 6 months
  description: after antiplatelet loading dose and after PCI in the occurrence of bleeding events
  measure: High Rap1b-GTP expression
  time frame: 12 months
  description: after antiplatelet loading dose and after PCI in the occurrence of bleeding events
  measure: Low Rap1b-GTP expression
  time frame: 1 month
  description: after antiplatelet loading dose and after PCI in the occurrence of MACE
  measure: Low Rap1b-GTP expression
  time frame: 6 months
  description: after antiplatelet loading dose and after PCI in the occurrence of MACE
  measure: Low Rap1b-GTP expression
  time frame: 12 months
  description: after antiplatelet loading dose and after PCI in the occurrence of MACE
  measure: Low Rap1b-GTP expression
  time frame: 12 months
  description: after antiplatelet loading dose and after PCI in the occurrence of bleeding events
  measure: High MV procoagulant and profibrinolytic expressions
  time frame: 1 month
  description: after antiplatelet loading dose and after PCI, in the occurrence of MACE
  measure: High MV procoagulant and profibrinolytic expressions
  time frame: 6 months
  description: after antiplatelet loading dose and after PCI, in the occurrence of MACE
  measure: High MV procoagulant and profibrinolytic expressions
  time frame: 12 months
  description: after antiplatelet loading dose and after PCI, in the occurrence of MACE
  measure: High MV procoagulant and profibrinolytic expressions
  time frame: 6 months
  description: after antiplatelet loading dose and after PCI, in the occurrence of bleeding
  measure: High MV procoagulant and profibrinolytic expressions
  time frame: 12 months
  description: after antiplatelet loading dose and after PCI, in the occurrence of bleeding
  arm group label: CKD patients
  arm group type: Experimental
  intervention type: Biological
  intervention name: Blood samples
  description: 12-24 hours after P2Y12 ADP receptor loading dose (LD)
  arm group label: CKD patients
  intervention type: Biological
  intervention name: Blood samples
  description: 1 month after Percutaneous Coronary Intervention (PCI)
  arm group label: CKD patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: FRANCOIS CREMIEUX
  role: Study Director
  affiliation: Assistance Publique Hopitaux Marseille
  last name: LAURENT BONELLO
  phone: 0491968858
  email: laurent.bonello@ap-hm.fr
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Acute Coronary Syndrome