Hepatic Safety of Statin Use in Neurology Inpatients

Recruiting

• Conditions: Statin Adverse Reaction
• Interventions: Other: stain

• Registration Number: NCT06592196
• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-10
• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-19
• Primary Completion: 2024-10-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Patients hospitalized in the Department of Neurology of Yueyang Hospital from June 2020 to February 2023.
2. Age ≥18 and ≤85 years old, both sexes.
3. Meet the diagnostic criteria of cerebrovascular disease (L1-8B0), headache disease (L1-8A8) and dizziness and vertigo (MB48) in ICD-11.

Exclusion Criteria

1. Incomplete medical history.
2. 1 days ≤ patients with < 7 days of prior statin use.
3. 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cross-sectional study and retrospective cohort study	stain	This research was conducted in two phases. Initially, a cross-sectional study was performed to assess the correlation between statin usage prior to hospital admission and the initial state of liver enzymes among patients. Subsequently, a retrospective cohort study was undertaken, wherein patients who had not been on statins prior to admission were categorized into two groups based on their statin usage post-admission.

Primary Outcome Measures

Name	Time	Method
Aspartate aminotransferase(AST)	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)	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.

Trial Locations

Locations (1)

Shanghai Yueyang Integrated Medicine Hospital; 🇨🇳 Shanghai, Shanghai, China