NCT06431789招募中不适用
Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
Yi Han1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Anti-factor Xa activity
研究概览
简要总结
- To provide reference for clinical rational use of edoxaban;
- Optimize the individualized dosing regimen of edoxaban.
详细描述
In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula
- •Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment
- •Patients voluntarily participate and sign informed consent
排除标准
- •Age < 18 years old
- •Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease
- •The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion
结局指标
主要结局
Anti-factor Xa activity
时间窗: six months
Anti-factor Xa activity
次要结局
未报告次要终点
研究者
Yi Han
Associate professor of pharmacy
Qianfoshan Hospital
研究点 (1)
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