Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowerin
The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one y
| Condition(s) | Acute Coronary Syndromes |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one year, and the incidence of adverse cardiovascular events. The primary research question is whether early initiation of PCSK9 inhibitor therapy during hospitalization for ACS patients in a real-world Chinese setting can increase the rate of lipid goal attainment, shorten the time to reach guideline-recommended lipid levels within one year, and improve the risk of adverse cardiovascular events. Researchers will compare three lipid-lowering strategies: PCSK9 inhibitor therapy (wi |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years. 2. This hospitalization for ACS, which includes ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unstable angina pectoris (UA) with a GRACE score of intermediate to high risk. 3. Written informed consent must be obtained from eligible patients prior to study enrollment. 4. LDL-C ≥1.8 mmol/L in patients using statin; LDL-C ≥2.6 mmol/L in those not taking statin in the last 4 weeks. Exclusion Criteria: 1. Received PCSK9 inhibitor therapy within 3 months. 2. Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure. 3. Patient has a history of renal or cardiac transplantation. 4. The patient is a pregnant or breastfeeding woman or a wom |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Yun Dai Chen |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-12-16 |
| NCT ID | NCT06738758 |
| Official listing | https://clinicaltrials.gov/study/NCT06738758 |