Chronic Kidney Disease stage3INNOV CKD 1NCT06026436
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
A study testing Blood samples in people with Chronic Kidney Disease stage3, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease stage3
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- ST-segment elevation ≥1 mm in two or more contiguous ECG leads
- New or presumably new left bundle branch block (LBBB).
- ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction
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- 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.
Who cannot join
- - 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
GIULIANI ALEXANDRA, promotion.interne@ap-hm.fr
BONELLO LAURENT
About this study
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.
- Conditions
- Chronic Kidney Disease stage3
- Being tested
- Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
12-24 hours after P2Y12 ADP receptor loading dose (LD)
Blood samplesBiological
1 month after Percutaneous Coronary Intervention (PCI)
| Study group | Role | What they receive |
|---|---|---|
| CKD patients | Experimental | Not described Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing the predictive value of high aRap1b expression
after antiplatelet loading dose in the occurrence of MACE
Measured: 12 months
Secondary outcomes (14)
High Rap1b-GTP expression
after antiplatelet loading dose in the occurrence of MACE
Measured: 1 month
High Rap1b-GTP expression
after antiplatelet loading dose in the occurrence of MACE
Measured: 6 months
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Measured: 1 month
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Measured: 6 months
High Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Measured: 12 months
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of MACE
Measured: 1 month
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of MACE
Measured: 6 months
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of MACE
Measured: 12 months
Low Rap1b-GTP expression
after antiplatelet loading dose and after PCI in the occurrence of bleeding events
Measured: 12 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of MACE
Measured: 1 month
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of MACE
Measured: 6 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of MACE
Measured: 12 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of bleeding
Measured: 6 months
High MV procoagulant and profibrinolytic expressions
after antiplatelet loading dose and after PCI, in the occurrence of bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start12 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCOIS CREMIEUX, Study director, Assistance Publique Hopitaux Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026436
- Sponsor's protocol ID
- RCAPHM23_0073 - INNOV-CKD1
- Acronym
- INNOV CKD 1
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06026436
- Acronym / sponsor ID
- INNOV CKD 1 / RCAPHM23_0073 - INNOV-CKD1
- Conditions
- Chronic Kidney Disease stage3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD patients | Experimental | Biological: Blood samples |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (20 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples12-24 hours after P2Y12 ADP receptor loading dose (LD) | Biological | CKD patients |
| Blood samples1 month after Percutaneous Coronary Intervention (PCI) | Biological | CKD patients |
Primary outcome
assessing the predictive value of high aRap1b expression
Time frame: 12 months
after antiplatelet loading dose in the occurrence of MACE
14 secondary outcomes
High Rap1b-GTP expression
Time frame: 1 month
High Rap1b-GTP expression
Time frame: 6 months
High Rap1b-GTP expression
Time frame: 1 month
High Rap1b-GTP expression
Time frame: 6 months
High Rap1b-GTP expression
Time frame: 12 months
Low Rap1b-GTP expression
Time frame: 1 month
Low Rap1b-GTP expression
Time frame: 6 months
Low Rap1b-GTP expression
Time frame: 12 months
Low Rap1b-GTP expression
Time frame: 12 months
High MV procoagulant and profibrinolytic expressions
Time frame: 1 month
High MV procoagulant and profibrinolytic expressions
Time frame: 6 months
High MV procoagulant and profibrinolytic expressions
Time frame: 12 months
High MV procoagulant and profibrinolytic expressions
Time frame: 6 months
High MV procoagulant and profibrinolytic expressions
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FRANCOIS CREMIEUX study director
Assistance Publique Hopitaux Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Chronic Kidney Disease stage3, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAURENT BONELLO (0491968858, laurent.bonello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing the predictive value of high aRap1b expression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.