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AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Brest
NCT05198960 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases. These diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status. In terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which i

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory). * Patients with JAK2V617F mutation (threshold allele burden \> 1%). * Patients considered as "high-risk" patients: 1. based on age (\> 60-year-old) 2. based on thrombotic history (compatible with antithrombotic randomization) but aged ≥ 18-year-old. * Length of time from MPN diagnostic to inclusion will not exceed 12 months. Exclusion Criteria: * Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding. * Formal indication of treatment with aspirin or DOAC (thus precluding randomization). * Inability to give informed consent. * Patients under curatorship/guardianship * Concomitant use of a strong inhibitor or inducer of CYP3A4 (like ruxolitinib). * Chronic liver disease or chronic hepatitis. * Renal insufficiency with creatinine \<30 ml/mn on Cockcroft and Gault Formula * Patient considered at high-risk of bleeding: patients with current or recent major or clinical relevant non major bleeding gastrointestinal or cerebral bleedings * Planned pregnancy within 24 months * No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman * PS\>2 or life expectancy \<12 months.
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What it tests

  • Direct Oral Anticoagulants
  • Low-dose aspirin
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Where

42 sites
CHU d'Angers
Angers, France
CH d'Annecy
Annecy, France
CH d'Argenteuil
Argenteuil, France
CH d'Avignon
Avignon, France
CH de la Côte Basque Bayonne
Bayonne, France
CH de Béziers
Béziers, France
CHU Bordeaux
Bordeaux, France
CHU Brest
Brest, France

…and 34 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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