Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive treatment group | patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe) |
| |
| Conventional combination therapy group | patients were treated with statin＋Ezetimibe/Hybutimibe |
| |
| control group | patients were treated with statin only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients judged by the investigator to be unsuitable for enrollment.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Li, professor | Contact | 8613810545564 | lidandan5564@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42137728 | Derived | Yu YN, Wang Y, Tuo XD, Li ZX, Li DD, Chen YD. Rationale and design of the Early Initiation of Intensification Lipid-Lowering Treatment in Acute Coronary Syndrome (ELITE-ACS): a real-world study. J Geriatr Cardiol. 2026 Apr 28;23(4):246-256. doi: 10.26599/1671-5411.2026.04.003. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
| The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups | Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization | 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 | Inflammatory factors include IL-6, CRP/Hypersensitive CRP | 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 |
| 12 months |
| The correlation between different baseline GRACE score levels (low, medium, high) and MACE | 12 months |
| The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE | 12 months |
| The correlation between different baseline age groups (≤ 45 years old or not) and MACE | 12 months |
| Percentage change in FAI measured by cardiac CT in patients undergoing elective PCI | FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA. | 12 months |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided