- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344610
Effects of Short-term Intensive Statin Therapy on Lipid Levels
January 7, 2026 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region
Effects of Short-term Intensive Statin Therapy on Lipid Levels in Patients With Ischemic Stroke or Large Artery Atherosclerosis: A Prospective Observational Study
Acute cerebral infarction (ACI), often linked to arterial stenosis, is a major cause of death and disability.
Statins are cornerstone therapies for secondary prevention, effectively lowering LDL-C and stabilizing plaques.
However, patient response to intensive statin therapy varies significantly.
This prospective study aims to analyze the short-term lipid-lowering effects and influencing factors of such therapy in ACI patients with stenosis, to guide personalized treatment and improve outcomes.
Study Overview
Study Type
Observational
Enrollment (Estimated)
800
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
-
-
Liaoning
-
Shenyang, Liaoning, China, 110840
- Recruiting
- Lu Wang
-
Contact:
- Yu Cui
- Phone Number: 862428897491
- Email: cuiyu.spu@hotmail.com
-
-
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
N/A
Sampling Method
Non-Probability Sample
Study Population
patients with ischemic stroke (within 14 days of onset) confirmed by cranial CT/MRI, or imaging-confirmed intracranial/extracranial atherosclerotic stenosis (stenosis rate ≥ 50%);
Description
Inclusion Criteria:
- Age ≥ 18 years;
- Diagnosis of ischemic stroke (within 14 days of onset) confirmed by cranial CT/MRI; or imaging-confirmed intracranial/extracranial atherosclerotic stenosis (stenosis rate ≥ 50%);
- Intensive statin therapy (e.g., atorvastatin 40-80 mg/day or rosuvastatin 20 mg/day) initiated within 24 hours of admission, with a planned continuous application for at least one week;
- Signed informed consent form.
Exclusion Criteria:
- Use of statin therapy within 1 week prior to admission;
- Receiving other lipid-lowering treatments;
- Presence of other serious comorbidities (e.g., malignant tumors, end-stage heart failure) with an expected survival of <1 year;
- Pregnant or lactating women;
- Participation in other drug clinical trials within 3 months;
- Other conditions deemed unsuitable by the investigator.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Absolute reduction in Low-Density Lipoprotein Cholesterol
Time Frame: 7±1 days
|
7±1 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Absolute and relative reductions in other lipid parameters (Total Cholesterol, Triglyceride, High-Density Lipoprotein Cholesterol, Lipoprotein a)
Time Frame: 7±1 days
|
7±1 days
|
|
Changes in high-sensitivity C-reactive protein
Time Frame: 7±1 days
|
7±1 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 8, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
January 7, 2026
First Submitted That Met QC Criteria
January 7, 2026
First Posted (Actual)
January 15, 2026
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Ischemic Stroke
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
Other Study ID Numbers
- Y (2025) 527
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
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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