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

Recruitingn/aAges 18 Years - anyAllYun Dai Chen
NCT06738758 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 stati

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📋 Eligibility rules (as published)
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.
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What it tests

  • PCSK9 inhibitor
  • Statin+Ezetimibe/Hybutimibe compound
  • Statin
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Where

1 site
Chinese PLA General Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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