Hepatic Safety of Statin Use in Neurology Inpatients

NCT06592196 | Recruiting

• 1 other identifier: 2024-154
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Statin Adverse Reaction

Outcome Measures

Primary Outcomes (2)

• Aspartate aminotransferase(AST)

  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.

  4weeks after admission.

• Alanine aminotransferase(ALT)

  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.

  4 weeks taken after admission.

Study Arms (1)

Cross-sectional study and retrospective cohort study

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.

Other: stain

Interventions

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.

Cross-sectional study and retrospective cohort study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients admitted to the Department of Neurology at Yueyang Hospital for cerebrovascular diseases, headaches, dizziness, and vertigo from June 2020 to February 2023.

You may qualify if:

• 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.

You may not qualify if:

• Incomplete medical history.
• 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).

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Coloring Agents

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: August 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: December 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)