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

NCT06738758 | Recruiting DMC

• 1 other identifier: ELITE-ACS
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary Syndromes; PCSK9 Inhibitor; Lipid compliance time and rate; First cardiovascular event

Outcome Measures

Primary Outcomes (1)

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

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

  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 (5)

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

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

  12 months

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

  12 months

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

  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

• Change from baseline in inflammatory factors

  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 (6)

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

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

  12 months

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

  12 months

Study Arms (3)

Intensive treatment group

patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe)

Drug: PCSK9 inhibitor

Conventional combination therapy group

patients were treated with statin＋Ezetimibe/Hybutimibe

Drug: Statin+Ezetimibe/Hybutimibe compound

control group

patients were treated with statin only

Drug: Statin

Interventions

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.

Intensive treatment group

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.

Conventional combination therapy group

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Dai Chen: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Central Study Contacts

Dandan Li, professor

CONTACT

8613810545564; lidandan5564@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 18, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-02

Locations

CN (1)