Hepatic Safety of Statin Use in Neurology Inpatients

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.

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Key information

Conditions

Statin Adverse Reaction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Jia Zhou

CONTACT

[email protected]

+86 21-6516-1782

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

stain

Other

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 outcomes

Aspartate aminotransferase(AST)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Yueyang Integrated Medicine Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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