Skip to content

The effect of PCSK9 inhibitor on the carotid atherosclerotic plaque in patients with acute coronary syndrome

The effect of PCSK9 inhibitor on the carotid atherosclerotic plaque in patients with acute coronary syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054126
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-09
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Acute coronary syndrome

Interventions

Treatment Group:Statins + Ezetimibe + PCSK9 inhibitor

Sponsors

the First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. >=18 years old, regardless of gender; 2. Diagnosed with acute coronary syndrome (including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris), and within 72 hours of onset; 3. The presence of dyslipidemia (LDL-c level > 2.6 mmol/l); 4. MR angiography of cervical vessels (limited carotid artery intima-media thickness >=2.0mm); 5. Has signed the informed consent for the study.

Exclusion criteria

Exclusion criteria: 1. Cardiogenic shock or require inotropic drugs or intra-aortic balloon counterpulsation (IABP) support; 2. Uncorrected circulatory congestion or valvular heart disease is expected to be frequently hospitalized or developed during follow-up; 3. In the acute exacerbation period of heart failure, unable to cooperate with lying down for a long time; 4. Have a history of hepatitis B or C; 5. The elevation of ALT is more than 3 times higher than the normal high value or the total bilirubin is more than 2 times higher than the normal high value; 6. Patients with pacemaker installed; 7. There are other causes of angina pectoris: such as severe aortic valve stenosis or insufficiency, coronary inflammation caused by rheumatic fever or other causes, coronary stenosis or occlusion caused by syphilitic aortitis, hypertrophic cardiomyopathy, congenital coronary anomalies; 8. Other serious cardiovascular and cerebrovascular events, such as stroke or transient ischemic attack, have occurred in the last three months; 9. Suffering from malignant tumors, multiple organ failure and other diseases that lead to short survival, and the expected life expectancy does not exceed 2 months; 10. Suffering from cognitive dysfunction, substance dependence, severe mental illness; 11. Intravenous drug addicts; 12. Pregnant or breastfeeding women, or planning to become pregnant or donate eggs during the study period; 13. Failure to cooperate with follow-up; 14. Participate in any other clinical trials at the same time; 15. Unable to understand or cooperate with all follow-ups; 16. Any other factors that may reduce compliance with the trial protocol; 17. The investigator believes that it is not suitable to participate in this clinical trial for any reason.

Design outcomes

Primary

MeasureTime frame
Carotid plaque fibrous cap thickness;

Secondary

MeasureTime frame
Plaque calcification score;Incidence of bleeding in the plaque;Number of lipid necrotic cores;Lumen stenosis degree;Serum LDL-c concentration;Heart systolic and diastolic function;6 minutes walking distance;Non-invasive cardiac output testing related indicators of cardiac function;

Countries

China

Contacts

Public ContactLiu Chen

The First Affiliated Hospital, Sun Yat-Sen University

liuch75@mail.sysu.edu.cn+86 15013270269

Outcome results

None listed

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