Hepatic Safety of Statin Use in Neurology Inpatients

September 11, 2024 updated by: Shanghai Yueyang Integrated Medicine Hospital

A Retrospective Study on the 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Yueyang Integrated Medicine Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4weeks after admission.
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.
4 weeks taken after admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2024

Primary Completion (Estimated)

October 10, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Estimated)

September 12, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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