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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Drug: Statin; Drug: PCSK9 inhibitor; Drug: Statin+Ezetimibe/Hybutimibe compound

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Dandan Li, professor; Phone Number: 8613810545564; Email: lidandan5564@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Dandan Li; Phone Number: 8613810545564; Email: lidandan5564@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for acute coronary syndrome (ACS). ACS is defined as STEMI, NSTEMI, and UA, where UA must be classified as high-risk in the GRACE score.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; patients were treated with statin only	Drug: Statin; The patient used statins in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.
Intensive treatment group; patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe)	Drug: PCSK9 inhibitor; The patient used PCSK9 inhibitor (with or without statins ± Ezetimibe/Hybutimibe) in the early hospitalization, and patients continually prescribed or stopped PCSK9 inhibitors treatment during the follow-up visit, which depend on physician's clinical decision and patient preference. PCSK9 inhibitors include Evolocumab, Alirocumab, Tafolecimab, Recaticimab, and Inclisiran, among others.
Conventional combination therapy group; patients were treated with statin＋Ezetimibe/Hybutimibe	Drug: Statin+Ezetimibe/Hybutimibe compound; The patient used statins and Ezetimibe/Hybutimibe in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups	Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization	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	Inflammatory factors include IL-6, CRP/Hypersensitive CRP	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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between LDL-C in-hospital compliance, 1-month compliance, and 3-month compliance with MACE		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 correlation between the duration of LDL-C within the target and MACE		12 months
The correlation between different baseline GRACE score levels (low, medium, high) and MACE		12 months
The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE		12 months
The correlation between different baseline age groups (≤ 45 years old or not) and MACE		12 months
Percentage change in FAI measured by cardiac CT in patients undergoing elective PCI	FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.	12 months

Collaborators and Investigators

• Sponsor: Yun Dai Chen

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Acute Coronary Syndromes; PCSK9 Inhibitor; Lipid compliance time and rate; First cardiovascular event
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Myocardial Ischemia; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antimetabolites; Serine Proteinase Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe; PCSK9 Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: ELITE-ACS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No