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NCT Number: NCT06738758

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

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Dandan Li

CONTACT

[email protected]

8613810545564

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PCSK9 inhibitor

Drug

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.

Statin+Ezetimibe/Hybutimibe compound

Drug

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.

Statin

Drug

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.

Primary outcomes

  1. Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)

    Time frame: 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 outcomes

  1. The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.

    Time frame: 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.

  2. The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups

    Time frame: 12 months

    Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization

  3. Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events

    Time frame: 12 months

  4. Percentage change from baseline in LDL-C across treatment groups at different visit nodes

    Time frame: 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

  5. Change from baseline in inflammatory factors

    Time frame: 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

Other outcomes

  1. The correlation between LDL-C in-hospital compliance, 1-month compliance, and 3-month compliance with MACE

    Time frame: 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

  2. The correlation between the duration of LDL-C within the target and MACE

    Time frame: 12 months

  3. The correlation between different baseline GRACE score levels (low, medium, high) and MACE

    Time frame: 12 months

  4. The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE

    Time frame: 12 months

  5. The correlation between different baseline age groups (≤ 45 years old or not) and MACE

    Time frame: 12 months

  6. Percentage change in FAI measured by cardiac CT in patients undergoing elective PCI

    Time frame: 12 months

    FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.

Study contacts

Contact information is provided by the study sponsor or research team.

Dandan Li, professor

CONTACT

[email protected]

8613810545564

Sponsors and collaborators

Lead sponsor

Yun Dai Chen

Other

Registry information

Official study title

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

Acronym: ELITE-ACS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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