CTIS2024-515362-13-00进行中（未招募）1 期
Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms - 29BRC20.0263
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,008
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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