Effects of Short-term Intensive Statin Therapy on Lipid Levels

NCT07344610 | Recruiting FDA Drug

• 1 other identifier: Y (2025) 527
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Absolute reduction in Low-Density Lipoprotein Cholesterol

  7±1 days

Secondary Outcomes (2)

• Absolute and relative reductions in other lipid parameters (Total Cholesterol, Triglyceride, High-Density Lipoprotein Cholesterol, Lipoprotein a)

  7±1 days

• Changes in high-sensitivity C-reactive protein

  7±1 days

Interventions

statin DRUG

Atorvastatin 40-80mg/day, Rosuvastatin 20mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%);

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Lu Wang

Shenyang, Liaoning, 110840, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)