Acute Coronary SyndromesELITE-ACSNCT06738758
Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)
An observational study of Acute Coronary Syndromes, run by Yun Dai Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- PCSK9 inhibitor, Statin+Ezetimibe/Hybutimibe compound and Statin
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Dandan Li, 8613810545564, lidandan5564@163.com
About this study
Official title: Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients
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.
Read more
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
- Being tested
- PCSK9 inhibitor, Statin+Ezetimibe/Hybutimibe compound, Statin
- Keywords
- Acute Coronary Syndromes, PCSK9 Inhibitor, Lipid compliance time and rate, First cardiovascular event
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitorDrug
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.
Statin+Ezetimibe/Hybutimibe compoundDrug
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.
StatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment group | patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe) Receives: Drug: PCSK9 inhibitor | |
| Conventional combination therapy group | patients were treated with statin＋Ezetimibe/Hybutimibe Receives: Drug: Statin+Ezetimibe/Hybutimibe compound | |
| control group | patients were treated with statin only Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.
Measured: 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
Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization
Measured: 12 months
Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events
Measured: 12 months
Percentage change from baseline in LDL-C across treatment groups at different visit nodes
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start16 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yun Dai Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Dai Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738758
- Sponsor's protocol ID
- ELITE-ACS
- Acronym
- ELITE-ACS
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42137728
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT06738758
- Acronym / sponsor ID
- ELITE-ACS / ELITE-ACS
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndromes, PCSK9 Inhibitor, Lipid compliance time and rate, First cardiovascular event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Yun Dai ChenUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment group | – | Drug: PCSK9 inhibitorpatients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe) |
| Conventional combination therapy group | – | Drug: Statin+Ezetimibe/Hybutimibe compoundpatients were treated with statin＋Ezetimibe/Hybutimibe |
| control group | – | Drug: Statinpatients were treated with statin only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCSK9 inhibitorThe 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. | Drug | Intensive treatment group |
| Statin+Ezetimibe/Hybutimibe compoundThe 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. | Drug | Conventional combination therapy group |
| StatinThe 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. | Drug | control group |
Primary outcome
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)
Time frame: 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
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)
5 secondary outcomes
The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.
Time frame: 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
Time frame: 12 months
Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events
Time frame: 12 months
Percentage change from baseline in LDL-C across treatment groups at different visit nodes
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 42137728Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Yun Dai Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dandan Li, professor (8613810545564, lidandan5564@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06738758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.