Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)
Launched by YUN DAI CHEN · Dec 13, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ELITE-ACS trial is studying how starting a specific type of medication called a PCSK9 inhibitor early during hospitalization can help patients with acute coronary syndrome (ACS). ACS includes serious heart conditions like heart attacks and unstable angina. Researchers want to see if this early treatment helps patients reach their cholesterol goals faster and reduces the chances of serious heart problems in the year following their hospital stay. They will compare three different treatment plans: one with the PCSK9 inhibitor combined with other medications, another with a combination of different cholesterol-lowering drugs, and the last with just a single type of cholesterol-lowering medication.
To participate in this study, you need to be at least 18 years old and currently hospitalized for ACS. You should also have certain cholesterol levels and a moderate to high risk for heart issues. If you join, you’ll receive one of the medication plans and have regular check-ups to monitor your health, including your cholesterol levels and any heart events. It’s important to know that certain health conditions or recent treatments may prevent you from participating, so it’s best to discuss your eligibility with your healthcare provider.
Gender
ALL
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.
About Yun Dai Chen
Yun Dai Chen is a dedicated clinical trial sponsor focused on advancing healthcare through innovative research and development. Committed to the highest standards of scientific integrity and ethical conduct, the organization specializes in the design, implementation, and management of clinical trials across various therapeutic areas. With a robust team of experienced professionals, Yun Dai Chen aims to facilitate the discovery and evaluation of novel treatments, ensuring that patient safety and regulatory compliance are paramount throughout the clinical research process. Through collaboration with leading medical institutions and researchers, the organization strives to contribute to the global advancement of medical knowledge and improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported