2024-515362-13-00尚未招募2/3 期
Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms
Centre Hospitalier Regional Et Universitaire De Brest42 个研究点 分布在 1 个国家目标入组 1,008 人开始时间: 2024年8月1日最近更新:
相关药物
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 1,008
- 试验地点
- 42
- 主要终点
- Time to occurrence of arterial or venous thromboembolic events
研究概览
简要总结
To demonstrate that low-dose DOAC is more effective than LDA in the primary prevention of arterial or venous thrombosis in JAK2V617F-positive high-risk MPN patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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
结局指标
主要结局
Time to occurrence of arterial or venous thromboembolic events
Time to occurrence of arterial or venous thromboembolic events
次要结局
- Time to occurrence of major and clinically relevant non-major bleedings as defined by ISTH
- Time to occurrence of arterial thromboembolic events
- Time to occurrence of venous thromboembolic events
- Time to occurrence of thromboembolic and bleeding events according to PV or ET or PreMF status
- Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs
- Time to occurrence of serious adverse events others than thromboses and hemorrhages
- Occurrence of atrial fibrillation episodes (time to occurrence)
- Overall survival and event free survival (events defined above) at 24 months
- Adjudicated mortality (non-cardiovascular and cardiovascular), time to occurence
- Therapeutic adherence will be studied (Girerd auto-questionnaire) during the study treatment period of 24 months
- Quality of life will be studied (EQ-5D-5L and MPN-SAF-TSS auto-questionnaire) during the study treatment period of 24 months
- Evaluation of costs and incremental cost utility ratio (cost per QALY) of low-dose DOAC compared to LDA
研究者
Pr Jean-Christophe IANOTTO
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (42)
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