Hepatic Safety of Statin Use in Neurology Inpatients
ConditionStatin Adverse Reaction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorShanghai Yueyang Integrated Medicine Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
stain
Other interventionThis 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.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Cross-sectional study and retrospective cohort study1 intervention
Trial outcomes
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.Sponsors and contacts
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Source ClinicalTrials.gov