Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)
研究概览
简要总结
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 (with or without statins ± Ezetimibe/Hybutimibe), statin plus Ezetimibe/Hybutimibe therapy, and statin monotherapy, to assess the potential of PCSK9 inhibitor drugs in accelerating lipid goal achievement and reducing adverse cardiovascular events in ACS patients.
Participants will:
Receive PCSK9 inhibitor therapy (with or without daily statins ± Ezetimibe/Hybutimibe) every two weeks, or daily statin plus Ezetimibe/Hybutimibe therapy, or daily statin monotherapy.
Undergo follow-up assessments of relevant laboratory indicators at baseline, 3 days after admission, discharge, and 1, 3, 6, and 12 months post-discharge.
Record the occurrence of major adverse cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •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.
- •Written informed consent must be obtained from eligible patients prior to study enrollment.
- •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.
排除标准
- •Received PCSK9 inhibitor therapy within 3 months.
- •Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.
- •Patient has a history of renal or cardiac transplantation.
- •The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.
- •Patients judged by the investigator to be unsuitable for enrollment.
研究组 & 干预措施
Intensive treatment group
patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe)
干预措施: PCSK9 inhibitor (Drug)
Conventional combination therapy group
patients were treated with statin＋Ezetimibe/Hybutimibe
干预措施: Statin+Ezetimibe/Hybutimibe compound (Drug)
control group
patients were treated with statin only
干预措施: Statin (Drug)
结局指标
主要结局
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)
时间窗: 3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge
Lipid attainment rate at each visit node during the observation period (\<1.4 mmol/L)
次要结局
- The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.(3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge)
- The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups(12 months)
- Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events(12 months)
- Percentage change from baseline in LDL-C across treatment groups at different visit nodes(3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge)
- Change from baseline in inflammatory factors(3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge)
研究者
Yun Dai Chen
professor
Chinese PLA General Hospital