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Hepatic Safety of Statin Use in Neurology Inpatients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06592196
Enrollment
2000
Registered
2024-09-19
Start date
2024-08-10
Completion date
2024-12-10
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Statin Adverse Reaction

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.

Interventions

OTHERstain

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.

Sponsors

Shanghai Yueyang Integrated Medicine Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026