NCT07384013招募中不适用
Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in DOAC
研究概览
简要总结
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
详细描述
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult oncology patients (≥18 years old).
- •Receiving apixaban or rivaroxaban for anticoagulation.
- •New/current metamizole users taking at least 1g TID for pain management.
- •Platelets ≥100×10⁹/L
- •ECOG PS<3
- •Provided informed consent
排除标准
- •History of allergic reaction to metamizole or DOACs.
- •Individuals with significant gastrointestinal disorders that may affect absorption, including (but not limited to) diagnosed bowel obstruction, persistent diarrhea, or the presence of a nasogastric tube (NGT/zonda)
研究组 & 干预措施
Cohort 1: Chronic metamizole users
Experimental
Patients receiving Optalgin prior to study enrollment
干预措施: metamizole (Drug)
Cohort 2: New metamizole users
Experimental
Patients receiving Optalgin after to study enrollment
干预措施: metamizole (Drug)
结局指标
主要结局
Change in DOAC
时间窗: 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment
Change in DOAC peak and trough concentrations during periods with and without metamizole comedication (5 different time points).
次要结局
未报告次要终点
研究者
研究点 (1)
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