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

Last updated: March 13, 2025
Sponsor: Yun Dai Chen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Coronary Artery Disease

Chest Pain

Treatment

Statin

Statin+Ezetimibe compound

PCSK9 inhibitor

Clinical Study ID

NCT06738758
ELITE-ACS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 GRACEscore of intermediate to high risk.

  3. Written informed consent must be obtained from eligible patients prior to studyenrollment.

  4. LDL-C ≥1.8 mmol/L in patients using statin; LDL-C ≥2.6 mmol/L in those not takingstatin in the last 4 weeks.

Exclusion

Exclusion Criteria:

  1. Received PCSK9 inhibitor therapy within 3 months.

  2. Patient has any life-threatening severe disease, including severe liver injury andpersistent 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 becomepregnant.

Patients judged by the investigator to be unsuitable for enrollment.

Study Design

Total Participants: 6000
Treatment Group(s): 4
Primary Treatment: Statin
Phase:
Study Start date:
December 16, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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