Status:
RECRUITING
AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
Lead Sponsor:
University Hospital, Brest
Conditions:
Polycythemia Vera
Essential Thrombocythemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and...
Eligibility Criteria
Inclusion
- 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:
- based on age (\> 60-year-old)
- 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
- 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.
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 13 2027
Estimated Enrollment :
1308 Patients enrolled
Trial Details
Trial ID
NCT05198960
Start Date
July 13 2022
End Date
July 13 2027
Last Update
February 4 2025
Active Locations (42)
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1
CHU d'Angers
Angers, France, 49933
2
CH d'Annecy
Annecy, France, 74374
3
CH d'Argenteuil
Argenteuil, France, 95100
4
CH d'Avignon
Avignon, France, 84000