跳至主要内容
临床试验/NCT06592196
NCT06592196招募中不适用

A Retrospective Study on the Hepatic Safety of Statin Use in Neurology Inpatients

Shanghai Yueyang Integrated Medicine Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年8月10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
2,000
试验地点
1
主要终点
Aspartate aminotransferase(AST)

研究概览

简要总结

This research employs a cross-sectional study and a retrospective cohort study to analyze the liver safety of statin use among inpatients in the neurology department in China from different perspectives. The aim is to supplement evidence-based medicine and provide guidance for the clinical use of statins.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients hospitalized in the Department of Neurology of Yueyang Hospital from June 2020 to February
  • Age ≥18 and ≤85 years old, both sexes.
  • Meet the diagnostic criteria of cerebrovascular disease (L1-8B0), headache disease (L1-8A8) and dizziness and vertigo (MB48) in ICD-11.

排除标准

  • Incomplete medical history.
  • 1 days ≤ patients with < 7 days of prior statin use.
  • Patients with malignant tumors (ICD-11 code L1-2A0, L1-2A2, L1-2B5, L1-2E6 diseases) and hematological diseases (ICD-11 code L1-3A0, L1-3B1, L1-3B8 diseases).

结局指标

主要结局

Aspartate aminotransferase(AST)

时间窗: 4weeks after admission.

The specific value of AST, whether the AST was more than 1 times the upper limit of normal (\>1×ULN), and whether it was more than 3×ULN.

Alanine aminotransferase(ALT)

时间窗: 4 weeks taken after admission.

The specific value of ALT, whether the ALT was more than 1 times the upper limit of normal (\>1×ULN), and whether it was more than 3×ULN.

次要结局

未报告次要终点

研究者

发起方
Shanghai Yueyang Integrated Medicine Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Hepatic Safety of Statin Use in Neurology Inpatients | 临床试验