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RecruitingNCT06592196Updated Sep 19, 2024

Hepatic Safety of Statin Use in Neurology Inpatients

An observational study in Statin Adverse Reaction, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Statin Adverse Reaction
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

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

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).
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4weeks after admission.

  2. 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.

    Time frame: 4 weeks taken after admission.

06

Study locations

1 of 1 sites recruiting
  • Shanghai Yueyang Integrated Medicine Hospital
    Shanghai, Shanghai, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06592196
Lead sponsor
Shanghai Yueyang Integrated Medicine Hospital
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Aug 10, 2024
Primary completion
Oct 10, 2024 (estimated)
Completion
Dec 10, 2024 (estimated)
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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