Rationale and design of the Early Initiation of Intensification Lipid-Lowering Treatment in Acute Coronary Syndrome (ELITE-ACS): a real-world study.
Ya-Ni Yu, Ying Wang, Xiao-Dan Tuo...
https://pubmed.ncbi.nlm.nih.gov/42137728Actively Recruiting
Age: 18Years +
All Genders
ID06738758
Multicenter Real-World Cohort Study Evaluating Early Intensive Lipid-Lowering Therapy Impact on Acute Coronary Syndrome Patients
Led by Yun Dai Chen · Updated on 2025-03-17
6000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of starting PCSK9 inhibitor therapy early during hospitalization in Chinese patients with acute coronary syndrome (ACS). The study aims to see if this approach improves the rate of reaching recommended lipid levels, shortens the time to meet these goals within one year, and reduces adverse cardiovascular events. Three lipid-lowering strategies will be compared: PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe), statin plus Ezetimibe/Hybutimibe, and statin alone. Participants will receive one of the three treatments: PCSK9 inhibitor therapy every two weeks (with or without daily statins ± Ezetimibe/Hybutimibe), daily statin plus Ezetimibe/Hybutimibe therapy, or daily statin monotherapy. Treatment adjustments during follow-up depend on the physician's decisions and patient preferences. Follow-up visits will monitor laboratory indicators at baseline, 3 days after admission, at hospital discharge (5 to 10 days after admission), and at 1, 3, 6, and 12 months after discharge. During the study, participants will undergo blood tests to assess lipid levels and inflammatory markers at various time points. Researchers will track the occurrence of major adverse cardiovascular events over 12 months. The primary outcome is the lipid attainment rate at each visit, while secondary outcomes include time to reach lipid goals, incidence of cardiovascular events, and changes in LDL cholesterol and inflammatory factors. The total follow-up duration for each participant is 12 months.
CONDITIONS
Brief Title
Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalization for acute coronary syndrome including STEMI, NSTEMI, or unstable angina with intermediate to high GRACE risk score
- Written informed consent given before enrollment
- LDL cholesterol ≥1.8 mmol/L if using statins or ≥2.6 mmol/L if not using statins in the last 4 weeks
You will not qualify if you...
- Received PCSK9 inhibitor therapy within the last 3 months
- Life-threatening severe diseases such as severe liver injury or persistent high serum transaminases
- Severe renal failure
- History of renal or cardiac transplantation
- Pregnant, breastfeeding, or planning to become pregnant
- Patients judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months
Participants receive early intensive or conventional lipid-lowering therapy during hospitalization and continue prescribed treatment for up to 12 months, with adjustments based on physician's clinical decision and participant preference.
Visits at 3 days of medication, hospital discharge (5 to 10 days after admission), and at 1, 3, 6, and 12 months after discharge
Follow-up
Duration - 12 months
Participants are observed for cardiovascular events and lipid levels throughout the 12 months following treatment initiation.
Same visits as during treatment for outcome assessments
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Loading map...
Research Team
D
Dandan Li, professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here