Carotid plaque stability
Conditions
Interventions
Intervention group:PCSK9 inhibitors + statins
Control group:statin
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male Patient or female aged 18 years or older; 2. ACS patients with selective coronary angiography or coronary CTA; 3. Patients with carotid plaque confirmed by carotid ultrasound or carotid MR; 4. Patients received statin treatment with stable blood lipids meets the inclusion criteria and does not change the modulation regimen during the trial; 5. Patients who did not receive lipid-regulating therapy were treated with statins according to the treatment guidelines, and their blood lipids met the inclusion criteria; 6. Those who cannot tolerate statin therapy should meet the criteria of statin intolerance: 7. The LDL-C levels of the subjects met the following criteria: (1) After lipid-regulation therapy, the level of LDL-C decreased by less than 50% from baseline or LDL-C >= 1.4mmol/L after lipid stabilization; (2) In ASCVD patients who have received the maximum tolerated dose of statin therapy, the LDL-C is >= 1.0mmol/L if the vascular event occurs within 2 years (it does not need to be the same as the first event).
Exclusion criteria
Exclusion criteria: 1. Patients with clinical instability (hemodynamic or electrodynamic instability); 2. Patients with severe renal insufficiency(glomerular filtration rate<30 ml/min); 3. Patients with active liver disease or liver disorders; 4. Patients known statin intolerance; 5. Patients receiving Evolocumab or other PCSK9 inhibitor treatment; 6. Patients currently receiving a study equipment or drug research; 7. Patients with pregnant or lactating women; 8. Patients with allergic to PCSK9 inhibitors or relative contraindication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the number of carotid roots with unstable plaques;Changes in carotid plaque volume;rich in lipid-necrotic core volume changes of carotid plaques; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in carotid plaque area;rich in lipid-necrotic core area changes of carotid plaques;Changes in the minimum fibrous cap thickness of carotid plaque;Changes in carotid plaque load;Changes in percentage of carotid artery stenosis;Changes in carotid artery wall thickness;Changes in the percentage of lipids in carotid plaque;Changes of carotid artery plaque normalized wall index;Hematological indicators;Occurrence of an event; | — |
Countries
China
Contacts
Public ContactGuohai Su
Jinan Central Hospital
Outcome results
None listed