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)
| NCT ID | NCT06738758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yun Dai Chen |
| Condition | Acute Coronary Syndromes |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2024-12-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06738758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06738758 currently recruiting?
Yes, NCT06738758 is actively recruiting participants. Contact the research team at lidandan5564@163.com for enrollment information.
Where is the NCT06738758 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06738758 clinical trial?
NCT06738758 is sponsored by Yun Dai Chen. The trial plans to enroll 6,000 participants.