Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk Myeloproliferative Neoplasms Patients with Aspirin Resistance
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- prevalence of aspirin resistance
研究概览
简要总结
Patients with myeloproliferative neoplasm (MPN) could have laboratory aspirin resistance and then increasing dose of aspirin from once daily to twice daily regimen is suggested. However, it is not routinely recommended to perform platelet function testing to determine aspirin resistance in MPN patients. Moreover, it is not known whether increasing dose of aspirin would always correct aspirin resistance and significantly prevent the thrombotic events in MPN patients. Therefore, this study aims to compare the efficacy of once daily versus twice daily aspirin in high-risk MPN patients with aspirin resistance. MPN patients with laboratory aspirin resistance will be included in this prospective randomized study and platelet function testing will be repeated at one and six months later. Clinical thrombosis and side effect from aspirin will be recorded for at least 2 years after intervention.
详细描述
Inclusion criteria included adult (>=18 years) Philadelphia-negative MPN patients taking aspirin (81 mg/day). Exclusion criteria included concomitant active cancer, thrombocytopenia (platelet less than 50,000/uL), taking anticoagulant, platelet function test (LTA method) showing no aspirin resistance, active gastric disease, active bleeding. Termination criteria included not taking aspirin regularly, serious side effect from aspirin. Block of four randomization is used. LTA testing is repeated at month 1 and 6 in both arms. PFA200 method is also done at initial enrollment for comparison with LTA method. Follow-up outcome data of clinical thrombosis, bleeding complication and adverse events related with aspirin are collected. Comparative analysis of outcome data is performed between two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Philadelphia negative Myeloproliferative neoplasms aged at least 18 years old
排除标准
- •Concomitant other active malignancy or cured less than 6 months
- •Platelet count less than 50,000/microL
- •Receiving anticoagulant
- •Active peptic ulcer
- •Active bleeding or Planning to undergo procedure/operation with bleeding risk
- •No laboratory aspirin resistance with LTA method
研究组 & 干预措施
81-mg aspirin twice daily
81-mg aspirin twice daily
干预措施: 81-mg aspirin twice daily (Drug)
81-mg aspirin once daily
81-mg aspirin once daily
干预措施: 81-mg aspirin once daily (Drug)
结局指标
主要结局
prevalence of aspirin resistance
时间窗: At 1 month and 6 month after intervention
Laboratory aspirin resistance is determined by light transmission aggregometry using arachidonic acid (0.5 g/L) as agonist and result of aggregation \>= 20% is defined as resistance.
次要结局
- The incidence of thrombotic events(2 years)
研究者
Yingyong Chinthammitr
Assistant Professor
Siriraj Hospital