Status:
NOT_YET_RECRUITING
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
Lead Sponsor:
First Affiliated Hospital of Xinjiang Medical University
Conditions:
Carotid Plaque
Hyperlipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. Nonetheless, the impact of PCSK9 inhibitors on the stability of carotid plaques remains insu...
Detailed Description
In a meticulous study evaluating the impact of inclisiran on patients with atherosclerosis and carotid plaques, data were systematically gathered across multiple time points. The assessment encompasse...
Eligibility Criteria
Inclusion
- Patients with carotid plaques as indicated by ultrasound
- Men and women aged 18-75 years;
- LDL-C \>3.4 mmol/L without regular statin therapy or LDL-C \>1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
Exclusion
- \- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
- Prior use of PCSK9 inhibitors;
- Prior history of hemorrhagic stroke;
- Prior coronary artery bypass grafting or coronary intervention;
- Inability to perform OCT imaging or unclear imaging;
- Severe renal insufficiency (creatinine clearance \< 30 mL/min);
- Severe hepatic dysfunction;
- Baseline triglycerides \> 5.6 mmol/L;
- Pregnant or lactating women;
- Life expectancy not exceeding 1 year;
- In the judgment of the investigator, unsuitable for this study for any reason.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06586684
Start Date
September 20 2024
End Date
September 30 2026
Last Update
September 19 2024
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