Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma: A Prospective, Multicenter, Open-Label, Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Incidence of VTE within 6 months
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in Chinese MM patients at high risk for MM-associated VTE.
详细描述
Venous thromboembolism (VTE) is one of the most common and dangerous complications of Multiple Myeloma (MM). The occurrence of VTE can disrupt treatment plans, compromise patients' quality of life, and even threaten their lives, presenting significant challenges in clinical management. Although several guidelines recommend risk-stratified thromboprophylaxis, there is a deficiency in prospective validation, and most initial studies were conducted in Western cohorts. This prospective, multicenter, open-label, randomized study aims to compare the efficacy and safety of aspirin or rivaroxaban in preventing VTE in Chinese MM patients who are at high risk for VTE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed multiple myeloma (according to Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision))
- •High risk of VTE (according to Expert consensus on the prevention and treatment of multiple myeloma related venous thromboembolism in China (2022))
- •Life expectancy exceeding 12 months
- •Gender: not specified, Age: 18-90 years
- •Serum HIV antigen or antibody negative
- •HCV antibody negative, or HCV antibody positive with HCV RNA negative
- •Echocardiogram shows a left ventricular ejection fraction of ≥50%
- •Ability to sign an informed consent form
排除标准
- •Pregnant women or women who are breastfeeding
- •Active gastrointestinal ulceration
- •Active bleeding
- •When initiating treatment, platelet count below 50 G/L, or with PT prolonged by more than 3 seconds, and APTT prolonged by more than 10 seconds.
- •Abnormal liver function (ALT or AST greater than 3 times the upper limit of normal, or total bilirubin greater than 2 times the upper limit of normal)
- •Abnormal renal function (creatinine clearance < 30 mL/min)
- •Unable to cooperate in completing the clinical trial
- •Already enrolled in other clinical studies
- •Diagnosed with smoldering multiple myeloma or plasma cell leukemia
- •Patients already on antiplatelet therapy for other cardiovascular or cerebrovascular diseases.
研究组 & 干预措施
Aspirin
Aspirin,100mg qd, for six months
干预措施: Aspirin 100mg (Drug)
Rivaroxaban
Rivaroxaban, 10mg qd, for six months
干预措施: Rivaroxaban 10mg (Drug)
结局指标
主要结局
Incidence of VTE within 6 months
时间窗: 6 months
Participants will receive a chest X-ray (or lung CT scan) and a color Doppler ultrasound of the limb blood vessels before the study begins, and then once monthly for the next six months.
次要结局
- Side effects of aspirin and rivaroxaban within 6 months(6 months)