RecruitingNCT06738758

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

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

Sponsor

Yun Dai Chen

Enrollment

6,000 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

Acute Coronary Syndromes

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

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.

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Interventions

DRUGPCSK9 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.

DRUGStatin+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.

DRUGStatin

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.