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Recruiting NCT06592196

Hepatic Safety of Statin Use in Neurology Inpatients

Observational Statin Adverse Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stain.
Who it may be relevant to
Registry conditions: Statin Adverse Reaction. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other 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

  • Aspartate aminotransferase(AST) [Time frame: 4weeks after admission.]
  • Alanine aminotransferase(ALT) [Time frame: 4 weeks taken after admission.]

Eligibility criteria

Inclusion criteria

  • Patients hospitalized in the Department of Neurology of Yueyang Hospital from June 2020 to February 2023.
  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Shanghai Yueyang Integrated Medicine Hospital — Shanghai

Identifiers

NCT: NCT06592196 · 2024-154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗