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A prospective cohort study on the effects of eicosapentaenoic acid ethyl ester combined with statins on vascular aging in adults over 45 years old

A prospective cohort study on the effects of eicosapentaenoic acid ethyl ester combined with statins on vascular aging in adults over 45 years old

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118798
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Aging

Interventions

EPA + Statin Group:None
Statin Alone Group:None

Sponsors

Shanxi Bethune Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 45 years old, male or female not limited; 2. Have received stable statin treatment for >= 4 weeks; 3. Meet one of the following conditions: (1) Fasting triglycerides (TG) >= 1.7 mmol/L (150 mg/dL); (2) TG 10 m/s, or CAVI >= 9.0, or FMD= 0.9 mm or the presence of non stenogenic atherosclerotic plaque; 4. Able to understand and agree with the research content, voluntarily sign an informed consent form, and willing to complete follow-up.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or unstable ischemic stroke occurred within the past year; 2. Active bleeding or obvious bleeding tendency, or currently using anticoagulation therapy that is difficult to monitor stably (such as warfarin patients with unstable INR); 3. Active liver disease or abnormal liver function (ALT or AST>3 times the upper limit of normal); 4. Obvious renal insufficiency (eGFR<30 mL/min/1.73 m ² or creatinine clearance rate<30 mL/min); 5. Individuals who are allergic or intolerant to EPA, fish oil preparations, or statins; 6. Patients with an expected survival period of less than 3 months or concurrent malignant tumors (expected survival period of less than 1 year), severe heart failure (NYHA grade IV), or severe lung disease requiring long-term oxygen therapy; 7. Diagnosed with dementia, mental symptoms, or violent tendencies; 8. Pregnant or lactating women; 9. Currently participate in other intervention clinical trials that may affect the research results, or have recently (within the first 3 months of enrollment) received experimental drug treatment that may interfere with this study.

Design outcomes

Primary

MeasureTime frame
Carotid-Femoral Pulse Wave Velocity (cfPWV);

Secondary

MeasureTime frame
Carotid Intima-Media Thickness (CIMT);Liver/Kidney Function, CK;Flow-Mediated Dilation (FMD);Cardio-Ankle Vascular Index (CAVI);Lipid Profile (TG, TC, LDL-C, HDL-C);Inflammatory Cytokines (TNF-a, IL-1ß, IL-6);Major Adverse Cardiovascular Events (MACE);

Countries

China

Contacts

Public ContactChunxia Li

Shanxi Bethune Hospital

8722132@qq.com+86 351 836 8114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026