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Efficacy and safety of combined probucol lipid-lowering therapy:Multi-Center Observational Study

Efficacy and safety of combined probucol lipid-lowering therapy:Multi-Center Observational Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122193
Enrollment
Unknown
Registered
2026-04-10
Start date
2025-01-16
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

atherosclerosis

Interventions

Probucol group:NA

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.According to the "2023 China Guidelines for Lipid Management ", individuals are defined as belonging to the high-risk or above category of ASCVD. 2.Prescription: Probucol 0.25g bid or 0.5g bid; 3. After regularly taking moderate-dose statins for 4 weeks, the patient's LDL-C level is >1.8 mmol/L. The LDL-C level of the patient who has not taken lipid-lowering drugs is >3.4 mmol/L. 4. Age range from 18 to 80 years old.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction within 30 days (due to unstable blood lipids caused by the acute phase of the disease itself, not due to drug factors); 2. Patients with persistent ventricular tachycardia, third-degree atrioventricular block, and torsade de pointes; 3. Patients with prolonged Q-Tc interval (Q-Tc > 500ms), or those who are currently using other medications that may cause prolongation of the Q-Tc interval; 4. Previous history of cardiogenic syncope or syncope of unknown cause; 5. High-dose statins (atorvastatin 40-80mg/d or rosuvastatin 20mg/d) and/or fibrates have been used; 6. Having taken probucol for more than 4 weeks before enrollment, or known to be allergic or intolerant to probucol; 7. Patients with decompensated heart failure, New York Heart Association functional class IV; 8. Abnormal liver function (liver dysfunction is defined as ALT and/or AST levels >2 times the upper limit of normal, accompanied by elevated bilirubin levels, or ALT and/or AST levels >3 times the upper limit of normal); 9. Hemodialysis patients; 10. Anemic patient (Hb: <90g/dL); 11. Patients with acute infection; 12. Patients with malignant tumors; 13. Active phase of autoimmune disease; 14. Women during pregnancy and those preparing for pregnancy; 15. There are situations that researchers believe they can not participate in.

Design outcomes

Primary

MeasureTime frame
Low density lipoprotein cholesterol, LDL-C;

Secondary

MeasureTime frame
Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST) ; Creatine Kinase (CK); Troponin I (TnI); Glycated Hemoglobin (HbA1c);corrected QT interval;High-Density Lipoprotein Cholesterol (HDL-C); Triglycerides (TG); Total Cholesterol (TC); Superoxide Dismutase (SOD) ; High-Sensitivity C-Reactive Protein (hs-CRP);

Countries

China

Contacts

Public ContactDaqing Zhang

Shengjing Hospital of China Medical University

zhangdaqing@vip.163.com+86 189 4025 5581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026