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Study on the effect and underlying mechanism of Xuezhikang on vulnerable carotid plaques in hypertensive populations based on contrast-enhanced ultrasound (CEUS) imaging

Study on the effect and underlying mechanism of Xuezhikang on vulnerable carotid plaques in hypertensive populations based on contrast-enhanced ultrasound (CEUS) imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100525
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Carotid atherosclerosis

Interventions

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate and sign an informed consent form; 2.Age greater than 18 years at screening, regardless of gender; 3.Diagnosed with hypertension [Hypertension: defined as three measurements on different days of systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg, or currently using antihypertensive medications] with one or more risk factors [smoking, low high-density lipoprotein cholesterol (HDL-C), age >=45/55 years (male/female)]; 4.Carotid ultrasound showing low echogenic or heterogeneous plaques with less than 50% carotid stenosis [Arterial plaque is defined as a local intima-media thickness of 1.5 mm or more, protruding into the lumen, or at least 0.5 mm or 50% thicker compared to the surrounding intima-media thickness]; 5.Fasting serum LDL-C level < 3.0 mmol/L and fasting serum TG level < 5.6 mmol/L; 6.No statin use in the past month; 7.Not diagnosed with ASCVD.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to the ingredients of Xuezhikang; 2.Clear history of coronary heart disease (CAG or CTA indicating coronary artery stenosis =50%) or clinical manifestations requiring reperfusion therapy for ASCVD; 3. Active liver disease or abnormal liver function, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels exceeding 1.5 times the upper limit of the reference range; or significantly elevated creatinine (creatinine > 250 µmol/L); 4.Creatine kinase (CK) levels exceeding 1.5 times the upper limit of the normal reference range; 5.Concurrent use of medications affecting lipid metabolism, such as glucocorticoids, estrogens, retinoids, cyclosporine, antidepressants, vascular endothelial growth factor inhibitors, aromatase inhibitors, etc.; 6.Concurrent diseases affecting lipid metabolism, such as liver disease, nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, multiple myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, etc.; 7.Pregnant or breastfeeding women; 8.Individuals currently participating in other clinical trials; 9.Individuals with unstable clinical status, severe heart or lung failure, uncontrolled arrhythmias, cancer history, life expectancy less than 1 year, or those judged by the investigator as unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
LDL-C reduction;Assessment of carotid plaques;

Secondary

MeasureTime frame
Blood biochemical markers;Other lipid parameters;Inflammatory factors and biomarkers;Plaque stability and endothelial function-related mediators;

Countries

China

Contacts

Public ContactSun Yanyi

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

syy12491@rjh.com.cn+86 18817821263

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026