NCT05225077Unknown4 期
Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of contrast induced nephropathy
研究概览
简要总结
This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age>18 years
- •Written informed consent
- •Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 [CKD stage G1-G3]
- •Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
排除标准
- •Active malignancy
- •Class I or equivalent indication for treatment with a SGLT2 inhibitor
- •Pregnancy or willing of pregnancy during the follow up period
- •Active urogenital infection
- •Diabetes mellitus type 1
- •History of diabetic ketoacidosis
- •Cardiogenic shock
- •eGFR < 29 ml/min/1.73m2
研究组 & 干预措施
Dapagliflozin 10mg group
Active Comparator
Dapagliflozin 10 mg once a day for 1 month after the procedure.
干预措施: Dapagliflozin 10 MG [Farxiga] (Drug)
结局指标
主要结局
Incidence of contrast induced nephropathy
时间窗: 48 hours
Serum creatinine (Scr) elevation of \>25% or \>0.5 mg/dl (44 μmol/l) from baseline within 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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