Prognostic Value of NETosis Markers for Thrombosis During Myeloproliferative Neoplasms (AVATARE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-09

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

NCT01559207

Venous Thromboembolism

COMPLETED

Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis

NCT03265054

Venous Thromboembolism (VTE)

UNKNOWN

Epidemiology of Thromboembolism Disease: A Cohort Study

NCT00670540

Vascular Diseases Embolism and Thrombosis Phlebitis +2 more

COMPLETED

Prevention of Thrombosis Recurrence in Patients With Low Circulating Levels of Antithrombin.

NCT01382550

Venous Thrombosis

UNKNOWN

Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

NCT00788736

Venous Thromboembolism

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

JAK2V617F positive myeloproliferative neoplasms (MPNs) are clonal disorders of hematopoietic stem cells characterized by an increased risk of thrombosis, the main cause of morbidity and mortality in these patients. Classical risk factors for thrombosis include a prior thrombotic event and age over 60. However, these criteria are often insufficient, as some patients who receive treatment continue to experience thrombosis, while others may be overtreated based solely on age. Recent studies have highlighted the role of neutrophil extracellular traps (NETs) in thrombosis, suggesting that NETosis, the process of NET formation, contributes to the activation of hemostasis and coagulation. Increased levels of NETs have been observed in patients with MPNs, particularly those with a history of thrombosis. Aspirin has shown a potential to reduce NET formation and the occurrence of thrombosis by inhibiting platelet-triggered NETosis. This study aims to prospectively evaluate the prognostic value of NETosis markers to predict thrombosis and optimize thrombotic prevention strategies in JAK2V617F-positive MPN patients.

The AVATARE ancillary study is linked to the AVAJAK clinical trial, which compares the efficacy of aspirin versus direct oral anticoagulants (DOACs) in preventing thrombotic events. Patients included in the AVATARE study will undergo venous blood sampling at baseline (T0) and 12 months (T1) for NETosis markers, such as calprotectin and citrullinated histone H3 (H3Cit). Participants will be followed up for 24 months. Clinical data, including the occurrence of venous and arterial thrombotic events, will be collected during the study period. Blood samples will be taken at inclusion (T0) and at 12 months (T1). The progression of NETosis markers will be monitored, and their correlation with thrombotic outcomes will be assessed to understand the potential role of these markers in predicting future thrombotic events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myeloproliferative Neoplasm Myeloproliferative Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Direct oral anticoagulants (DOACs)

Group Type EXPERIMENTAL

Additional blood sampling

Intervention Type BIOLOGICAL

At inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis

Aspirin

Group Type ACTIVE_COMPARATOR

Additional blood sampling

Intervention Type BIOLOGICAL

At inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Additional blood sampling

At inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* Enrollment in the AVAJAK clinical trial and the FIMBANK biobank
* Affiliation with social security
* Signed informed consent

Exclusion Criteria

* Severe hepatic or renal insufficiency (Creatinine clearance \<30ml/min)
* Patients under legal protection (guardianship or curatorship)
* Patients under heparin treatment at inclusion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandre GUY

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.