Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms

Phase 1

• Conditions: Philadelphia-negative myeloproliferative neoplasms are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF).; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-515362-13-00
• Lead Sponsor: Centre Hospitalier Regional Et Universitaire De Brest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-04
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1008

Inclusion Criteria

Patients with diagnosis of Polycythemia Vera or Essential Thrombocythemia or Prefibrotic myelofibrosis 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, No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman, PS>2 or life expectancy <12 months, Formal indication of treatment with LDA 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 clinically relevant non major bleeding gastrointestinal or cerebral bleedings, Planned pregnancy within 24 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified