Clinical trial 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)
Official title: Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes
PCSK9 Inhibitor
Lipid compliance time and rate
First cardiovascular event
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Primary outcomes:
measure: Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)
timeFrame: 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 outcomes:
measure: The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.
timeFrame: 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
measure: The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups
timeFrame: 12 months
measure: Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events
timeFrame: 12 months
measure: Percentage change from baseline in LDL-C across treatment groups at different visit nodes
timeFrame: 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
measure: Change from baseline in inflammatory factors
timeFrame: 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 outcomes:
measure: The correlation between LDL-C in-hospital compliance, 1-month compliance, and 3-month compliance with MACE
timeFrame: 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
measure: The correlation between the duration of LDL-C within the target and MACE
timeFrame: 12 months
measure: The correlation between different baseline GRACE score levels (low, medium, high) and MACE
timeFrame: 12 months
measure: The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE
timeFrame: 12 months
measure: The correlation between different baseline age groups (≤ 45 years old or not) and MACE
timeFrame: 12 months
measure: Percentage change in FAI measured by cardiac CT in patients undergoing elective PCI
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: