Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)

Recruiting

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: PCSK9 inhibitor; Drug: Statin+Ezetimibe/Hybutimibe compound; Drug: Statin

• Registration Number: NCT06738758
• Lead Sponsor: Yun Dai Chen

Brief 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 (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-13
• Study Start: 2024-12-16
• Study First Posted: 2024-12-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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 woman planning to become pregnant.

Patients judged by the investigator to be unsuitable for enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive treatment group	PCSK9 inhibitor	patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe)
Conventional combination therapy group	Statin+Ezetimibe/Hybutimibe compound	patients were treated with statin＋Ezetimibe/Hybutimibe
control group	Statin	patients were treated with statin only

Primary Outcome Measures

Name	Time	Method
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)	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)

Secondary Outcome Measures

Name	Time	Method
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 average time for different treatment groups to reach the guideline-recommended lipid standards (\<1.4mmol/L) during the observation period.
The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups	12 months	Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization
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	Inflammatory factors include IL-6, CRP/Hypersensitive CRP

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China