Cardio-cerebro-vascular disease
Conditions
Interventions
Exposed Group (Combined use of the PCSK9 inhibitor evolocumab/alirocumab on the basis of standard therapy):None
Control Group (Moderate-intensity statin therapy (atorvastatin 20 mg / rosuvastatin 10 mg) combined with a cholesterol absorption inhibitor (such as ezetimibe)):None
Sponsors
The Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Age >= 18 years, no restriction on sex; (2) Patients with a presumed diagnosis of acute coronary syndrome (ACS); (3) Baseline LDL-C >= 1.8 mmol/L or non-HDL-C >= 2.6 mmol/L; (4) Able to tolerate statin and PCSK9 inhibitor therapy; (5) Meet the basic safety requirements for cardio-cerebral combined CTA scanning, with no contraindications to CTA examination; (6) Voluntarily participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Safety-related high-risk exclusions (already excluded) (1) Hemodynamic instability (requiring vasopressor support and/or mechanical assistance), Killip class III–IV or NYHA class IV, or unstable acute phase of STEMI; (2) Major bleeding within the past 30 days or uncontrolled significant bleeding risk; (3) eGFR < 45 mL/min/1.73m², dialysis dependence, history of severe adverse reaction to contrast media, uncontrolled hyperthyroidism, severe hepatic dysfunction, pregnancy, lactation, planned pregnancy, or individuals sensitive to radiation exposure; (4) Known adverse reactions to the planned study medication. 2. Factors potentially interfering with efficacy evaluation or imaging interpretation (already excluded) (1) Planned carotid endarterectomy/stenting or other coronary revascularization procedures within 3 months; (2) Target vessels with prior stent implantation, bypass grafting, or metallic artifacts affecting quantitative assessment; (3) Inability to maintain stable lipid-lowering and anti-atherosclerotic therapy (other than the study drug) according to the protocol, or anticipated frequent therapy adjustments; (4) Active systemic inflammatory or autoimmune disease, active malignancy, or severe infection; (5) Persistent arrhythmia or uncontrolled heart rate leading to non-evaluable CTA imaging; (6) Baseline CTA image quality not meeting the standard or key segments non-assessable; (7) Participation in other interventional clinical trials; (8) Refusal to participate or inability to complete follow-up visits as scheduled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of cardiovascular or cerebrovascular adverse events during the 12-month efficacy observation period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cardio-cerebrovascular plaque burden;Changes in low-density lipoprotein cholesterol (LDL-C); | — |
Countries
China
Contacts
Public ContactChen Tao
The Sixth Medical Center of PLA General Hospital
Outcome results
None listed