atherosclerotic cardiovascular disease (ASCVD)
Conditions
Interventions
Group 1:statin combined with eloyuumab
Group 2:statin combined with ezetimibe
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 85 years, regardless of gender; 2. Clinically diagnosed as ultra-high-risk atherosclerotic cardiovascular disease (ASCVD): patients with >= 2 severe ASCVD events or 1 severe ASCVD event combined with >= 2 high-risk factors are ultra-high-risk ASCVD patient: (1) Severe ASCVD includes: 1) ACS has occurred recently (within the past 12 months); 2) History of myocardial infarction (over 12 months); 3) History of ischemic stroke; 4) Symptomatic peripheral vascular disease, who has received revascularization or amputation in the past. (2) High-risk factors include: 1) Multiple vascular bed disease (coronary artery, cerebral artery and peripheral artery have 2~3 ischemia at the same time Symptomatic arterial disease); 2) Early onset of coronary heart disease (male 4.9 mmol/L; 4) Have a history of coronary artery bypass grafting or percutaneous coronary intervention; 5) Diabetes; 6) Hypertension; 7) Chronic kidney disease (stage 3/4); 8) Smoking; 9) After treatment with the maximum tolerated dose of statins, LDL-C is still >= 2.6 mmol/L. 3. The doctor prescribes the treatment of statin combined with eloyuumab or statin combined with ezetimibe; 4. The patient or his agent signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are contraindicated with statins, ezetimibe or have a history of intolerance; 2. People with severe allergies, known or likely to be allergic to iloyuumab injection (Rebam); 3. Hemorrhagic stroke has occurred in the past; 4. Stroke occurred within 1 month before screening; 5. Iloyuumab or other PCSK9 inhibitors and ezetimibe have been used within 6 months before screening; 6. Heart function classification is grade III or IV, or left ventricular ejection fraction < 30%; 7. Pregnant or lactating women; 8. Participate in other clinical trials within 1 month before screening; 9. The investigator judged that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C;Lp(a);Platelet glycoprotein CD62; | — |
Secondary
| Measure | Time frame |
|---|---|
| TC;HDL-C;TG;Adverse reactions;Adverse events; | — |
Countries
China
Contacts
Public ContactKe Xia
Xiangya Hospital, Central South University
Outcome results
None listed