Type 2 diabetes and atherosclerotic cardiovascular Disease (ASCVD)
Conditions
Interventions
Recasicumab Treatment Group:Riccimab was subcutaneously injected at 150mgQ4W/ 300mg Q8w for 24 weeks
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Diagnose type 2 diabetes; 3. Diagnosis of atherosclerotic cardiovascular disease (ASCVD); ASCVD includes acute coronary syndrome (ACS), ischemic cardiomyopathy, stable coronary heart disease, post-coronary revascularization, ischemic stroke, transient ischemic attack (TIA), peripheral artery disease (PAD), or post-coronary revascularization. 4. Fasting LDL-C >= 1.4 mmol/L; 5. Fasting triglycerides <=5.6 mmol/L; 6. Patients using riccimab for injection; 7. Voluntarily sign the informed consent form before the start of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial;
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women, as well as women of childbearing age who are unwilling to take reliable contraceptive measures; 2. When screening, patients diagnosed with familial hypercholesterolemia (FH) or those who have already been diagnosed with FH according to the diagnostic criteria of the Chinese Expert Consensus on Screening, Diagnosis and Treatment of Familial Hypercholesterolemia (2018); Adults can be diagnosed with FH if they meet two of the following criteria: (1) The serum LDL-C level of patients who have not received lipid-regulating drug treatment is >=4.7 mmol/L(180 mg/dl); (2) There is yellow skin/tendon Tumors or lipid corneal arches in people under 45 years old; (3) There is FH or early-onset ASCVD in first-degree relatives, especially patients with coronary heart disease. 3. Cardiac function grade IV as defined by the New York Heart Association (NYHA) or left ventricular ejection fraction (LVEF) =180 mmHg and/or diastolic blood pressure >=110 mmHg; 5. Uncontrolled severe arrhythmias, such as obvious ventricular tachycardia, second-degree type II or third-degree cardiac block without a pacemaker installed; 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds three times the upper limit of normal (ULN), or total bilirubin exceeds two times ULN; 7. The calculated glomerular filtration rate (eGFR) is less than 30 ml/min/1.73m^2; Within 8.3 months, PCSK9 monoclonal antibody has been used, or Inkesilan has been used; 9. History of malignant tumors; 10. Patients who participated in other clinical trials within one month; 11. In addition to the above, patients who the researchers determine are not suitable to participate in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change of LDL-C from baseline after 24 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event incidence;The change value of LDL-C relative to baseline after 24 weeks of treatment;The percentage change and change value of LDL-C relative to baseline after 8 and 16 weeks of treatment;The target attainment rate of LDL-C after 8, 16 and 24 weeks of treatment;The percentage changes and change values of non-HDL-C, TG and HDL-C relative to the baseline after 8, 16 and 24 weeks of treatment.; | — |
Countries
China
Contacts
Public ContactLiu Shiwei
Shanxi Bethune Hospital
Outcome results
None listed