patients with ASCVD or at high risk of ASCVD
Conditions
Interventions
Recaticimab 300 mg Q8W:Recaticimab 300 mg IH Q8W
Recaticimab 450 mg Q12W:Recaticimab 450 mg IH Q12W
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age>= 18 years; 2.Diagnosed atherosclerotic cardiovascular disease (ASCVD) or at high risk of ASCVD; # Patients at high risk of ASCVD are defined as: patients classified as high-risk according to the overall risk assessment of ASCVD in Chinese adults according to the Chinese Guidelines for the Management of Lipids (2023): in the population without ASCVD, one of the following three conditions is met: (1) LDL-C >= 4.9 mmol/L or TC >= 7.2 mmol/L; (2) Diabetic patients aged >= 40 years; (3) CKD stage 3~4. Individuals who do not have any of the above 3 conditions (including patients with diabetes =10%) of ASCVD overall over the next 10 years; People with a 10-year risk of ASCVD at intermediate risk (5%~9%), if they are = 160 mmHg or diastolic blood pressure >=100 mmHg; (2) Non-HDL-C>= 5.2 mmol/L; (3)HDL-C= 28kg/m^2; (5) Smoking. 3.According to the Chinese guidelines for the management of lipids (2023 ) the overall risk stratification of ASCVD in Chinese adults meets the following criteria: super high risk of ASCVD patients fasting LDL-C>= 1.4 mmol/L, very high risk of ASCVD patients fasting LDL-C>= 1.8 mmol/L, high risk of ASCVD patients fasting LDL-C>= 2.6 mmol/L; 4.Fasting triglycerides<=5.6 mmol/L; 5.Voluntarily signed the informed consent form prior to the commencement of activities related to this trial, and able to understand the procedures and methods of this trial, and willing to strictly follow the clinical trial protocol to complete this trial.
Exclusion criteria
Exclusion criteria: 1.Pregnant, lactating, and women of childbearing potential who are unwilling to use reliable contraception; 2.Patients with familial hypercholesterolemia (FH) or confirmed FH according to the Chinese Expert Consensus on Screening and Diagnosis and Treatment of Familial Hypercholesterolemia (2018) diagnostic criteria at screening;FH is diagnosed in adults if they meet 2 of the following criteria: (1) blood clearance LDL-C level >=4.7 mmol/L (180 mg/dl) in patients who are not treated with lipid-modifying drugs; (2) people with cutaneous/tendon xanthoma or lipid corneal arch in = 180 mmHg and/or diastolic blood pressure >= 110 mmHg; 5.Uncontrolled severe arrhythmia, such as severe symptomatic ventricular tachycardia, severe atrioventricular block without pacemaker; 6.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3 ULN,TBIL >= 2 ULN; 7.eGFR < 30 ml/min/1.73m^2; 8.Prior use of PCSK9 monoclonal antibody within 3 months, or use of Inclisiran; 9.History of malignancy; 10.Patients who have participated in other clinical trials within 1 month; 11.Judged by the investigator to be unsuitable to participate in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood lipids (LDL-C, non-HDL-C, TG, ApoB, Lp(a), HDL-C); | — |
Countries
China
Contacts
Public ContactDaoquan Peng
Second Xiangya Hospital of CSU
Outcome results
None listed