Prognostic Value of NETosis Markers for Thrombosis During Myeloproliferative Neoplasms (AVATARE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
Myeloproliferative neoplasms are hematologic diseases characterized by an increased proliferation of peripheral blood cells. The main risk of MPN is the occurrence of thrombosis. Thrombosis risk is mainly evaluated using two criteria: age and prior thrombosis. A better prediction of thrombosis risk is needed to improve prevention and treatment of MPN-associated thrombosis. The objective of the study is to evaluate the predictive value of neutrophil extracellular traps markers in thrombosis during MPN.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Polycythemia Vera (PV), Essential Thrombocythemia (ET), or pre-myelofibrosis (pre-MF)
JAK2V617F mutation with an allelic burden greater than 1%
High risk of thrombosis (age over 60 years or prior thrombotic event)
Diagnosis of MPN within the last 12 months
Disqualifiers
Severe hepatic or renal insufficiency (Creatinine clearance <30ml/min)
Patients under legal protection (guardianship or curatorship)
Patients under heparin treatment at inclusion
Trial design
Design model
Parallel
Treatments tested in this trial
Additional blood sampling
Biological/VaccineAt inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Direct oral anticoagulants (DOACs)Experimental treatment 1 intervention
Group B: AspirinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum calprotectin concentration
This concentration will be compared between MPN patients who develop thrombotic events during the follow-up and those who do not. The serum concentration will be measured using automated immunoturbidimetric test and the results will be analyzed to assess its association with future thrombotic events in patients with myeloproliferative neoplasms.
Time frame
At T0 (inclusion)Secondary outcomes
1
Serum calprotectin concentration
Time frame
At T1 (12 months post-inclusion)2
Serum concentration of citrullinated histone H3 (H3Cit)
This concentration will be assessed to evaluate calprotectin concentration at T1 and to compare the evolution of this marker in patients treated by direct oral anticoagulant or by aspirin.
Time frame
At T1 (12 months post-inclusion)3
Plasma citrullinated histone 3 concentration
This concentration will be compared between MPN patients who develop thrombotic events during the follow-up and those who do not. The plasma concentration will be measured using ELISA test and the results will be analyzed to assess its association with future thrombotic events in patients with myeloproliferative neoplasms.
Time frame
At T0 (inclusion)4
Plasma citrullinated histone 3 concentration
This concentration will be assessed to evaluate citrullinated histone 3 concentration at T1 and to compare the evolution of this marker in patients treated by direct oral anticoagulant or by aspirin.
Time frame
At T1 (12 months post-inclusion)Sponsors and contacts
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Source ClinicalTrials.gov