Patients with ASCVD at moderate, high, very high, and ultra-high risk levels
Conditions
Interventions
Tafolecimab Extended Dosing Group:None
Tafolecimab Conventional Therapy Group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.>=18 years old; 2.Moderate-risk, high-risk, very-high-risk, and ultra-high-risk ASCVD populations; 3.Capable of providing informed consent; 4.Undergoing treatment with tafolecimab injection;
Exclusion criteria
Exclusion criteria: 1.low-high-risk ASCVD populations; 2.Currently participating in other medical device or drug studies; 3.Pregnant or breastfeeding; 4.Conditions that the investigator considers may compromise patient safety or affect compliance with the study protocol; 5.Patients judged by the investigator as ineligible for study participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained LDL-C goal achievement rate within 1 year, with specific criteria as follows: very-high-risk ASCVD patients: LDL-C 50% reduction from baseline; ultra-high-risk ASCVD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of overall safety (incidence of adverse events and serious adverse events) and tolerability (treatment discontinuation rate due to adverse events);Percentage changes from baseline in LDL-C, HDL-C, ApoB, and Lp(a) at 3, 6, 9, and 12 months; | — |
Countries
China
Contacts
Public ContactRong Jiang
Shanghai General Hospital
Outcome results
None listed