Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05198960
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05198960
Study Brief:
Protocol Section:
NCT05198960