Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Venous Thromboembolism (VTE)
研究概览
简要总结
This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Eligible participants will be randomized to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose LMWH. The primary objective is to evaluate the incidence of venous thromboembolism during a 6-month follow-up period. Secondary objectives include assessment of bleeding complications, overall survival, and treatment adherence. The results of this study may provide evidence for safer and more convenient thromboprophylaxis strategies in patients with blood cancers.
详细描述
Patients with hematologic malignancies are at high risk of developing venous thromboembolism (VTE). Low-molecular-weight heparin (LMWH) is currently the standard of care for thromboprophylaxis in this population; however, daily subcutaneous administration is burdensome and may impair adherence. Direct oral anticoagulants (DOACs), such as apixaban and rivaroxaban, have demonstrated efficacy in the prevention and treatment of VTE in patients with solid tumors, but data in hematologic malignancies are limited.
This study is designed as a prospective, randomized, open-label, parallel-group trial to compare the efficacy and safety of reduced-dose apixaban and rivaroxaban with standard-dose LMWH in patients with hematologic malignancies requiring primary thromboprophylaxis.
Approximately 100 patients will be randomized in a 1:1:1 ratio to receive:
Apixaban 2.5 mg orally twice daily, Rivaroxaban 10 mg orally once daily, or LMWH (enoxaparin 40 mg subcutaneously once daily or equivalent). The primary endpoint is the incidence of symptomatic or objectively confirmed VTE within 6 months of randomization. Secondary endpoints include major and clinically relevant non-major bleeding events (as defined by ISTH), treatment adherence, and overall survival at 6 months.
This study aims to address the unmet clinical need for optimized, patient-friendly thromboprophylaxis in hematologic malignancies and to provide high-quality data that may guide future clinical practice.
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
盲法说明
This is an open-label study; no masking will be applied.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active hematologic malignancy at the time of initiation of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma or other hematologic cancer with a Khorana score ≥ 2 points (intermediate or high risk of venous thromboembolism, VTE)
- •Use of anticoagulant agents for primary thromboprophylaxis, including direct oral anticoagulants (DOACs) at reduced doses (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or low-molecular-weight heparin (LMWH) (enoxaparin 40 mg subcutaneously once daily).
排除标准
- •Major bleeding within the last month (including gastrointestinal or intracranial bleeding).
- •Active major bleeding.
- •Hemoglobin concentration < 8 g/dL.
- •Thrombocytopenia with platelet count <30 × 10⁹/L.
- •ECOG performance status of 3 or
- •Expected survival <6 months.
- •History of mechanical heart valve or severe mitral stenosis.
- •Estimated glomerular filtration rate (eGFR) < 25 mL/min.
- •Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).
- •Acute coronary syndrome or ischemic stroke within the last 6 months.
- •Anticipated significant drug-drug interactions between DOACs and anticancer agents.
- •Known antiphospholipid syndrome (APS).
研究组 & 干预措施
RIVAROXABAN (reduced dose)
Participants receive rivaroxaban 10 mg orally once daily for at least 6 months.
干预措施: Rivaroxaban (Drug)
APIXABAN (reduced dose)
Participants receive apixaban 2.5 mg orally twice daily for at least 6 months.
干预措施: Apixaban (Drug)
Low-Molecular-Weight Heparin (LMWH)
Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months.
干预措施: low molecular weight heparin (enoxaparin sodium) (Drug)
结局指标
主要结局
Incidence of Venous Thromboembolism (VTE)
时间窗: 6 months from randomization
Number of patients who develop symptomatic or incidental venous thromboembolism (deep vein thrombosis or pulmonary embolism) confirmed by objective imaging during the study treatment period.
Incidence of Major Bleeding (ISTH criteria)
时间窗: 6 months from randomization
Number of patients experiencing major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).
Incidence of Clinically Relevant Non-Major Bleeding (CRNMB)
时间窗: 6 months from randomization
Number of patients experiencing clinically relevant non-major bleeding (CRNMB) according to ISTH definition.
次要结局
- Overall Survival(6 months)
- Treatment Discontinuation Due to Adverse Events(6 months)