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)

October 26, 2023 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
850

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille
        • Principal Investigator:
          • BONELLO LAURENT
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessing the predictive value of high aRap1b expression
Time Frame: 12 months
after antiplatelet loading dose in the occurrence of MACE
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
High Rap1b-GTP expression
Time Frame: 1 month
after antiplatelet loading dose in the occurrence of MACE
1 month
High Rap1b-GTP expression
Time Frame: 6 months
after antiplatelet loading dose in the occurrence of MACE
6 months
High Rap1b-GTP expression
Time Frame: 1 month
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
1 month
High Rap1b-GTP expression
Time Frame: 6 months
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
6 months
High Rap1b-GTP expression
Time Frame: 12 months
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
12 months
Low Rap1b-GTP expression
Time Frame: 1 month
after antiplatelet loading dose and after PCI in the occurrence of MACE
1 month
Low Rap1b-GTP expression
Time Frame: 6 months
after antiplatelet loading dose and after PCI in the occurrence of MACE
6 months
Low Rap1b-GTP expression
Time Frame: 12 months
after antiplatelet loading dose and after PCI in the occurrence of MACE
12 months
Low Rap1b-GTP expression
Time Frame: 12 months
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
12 months
High MV procoagulant and profibrinolytic expressions
Time Frame: 1 month
after antiplatelet loading dose and after PCI, in the occurrence of MACE
1 month
High MV procoagulant and profibrinolytic expressions
Time Frame: 6 months
after antiplatelet loading dose and after PCI, in the occurrence of MACE
6 months
High MV procoagulant and profibrinolytic expressions
Time Frame: 12 months
after antiplatelet loading dose and after PCI, in the occurrence of MACE
12 months
High MV procoagulant and profibrinolytic expressions
Time Frame: 6 months
after antiplatelet loading dose and after PCI, in the occurrence of bleeding
6 months
High MV procoagulant and profibrinolytic expressions
Time Frame: 12 months
after antiplatelet loading dose and after PCI, in the occurrence of bleeding
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: François CREMIEUX, Assistance Publique Hôpitaux Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCAPHM23_0073 - INNOV-CKD1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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