Actively Recruiting
A Single-center, Randomized Controlled Study Comparing Early Evolocumab Plus Standard Lipid-Lowering Therapy Versus Standard Therapy on Coronary Plaque Progression After Acute Coronary Syndrome Using Serial PCCT-CCTA
Led by West China Hospital · Updated on 2026-05-29
233
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of early use of evolocumab combined with standard lipid-lowering therapy compared to standard lipid-lowering therapy alone in patients who have had acute coronary syndrome (ACS) and successful percutaneous coronary intervention (PCI). The trial aims to see if early intensive lowering of LDL cholesterol with evolocumab can reduce the progression of coronary plaque and to assess photon-counting coronary computed tomography angiography (PCCT-CCTA) as a tool for monitoring changes in atherosclerotic plaques. This is a randomized, open-label study with blinded endpoint assessment conducted at a single center.
CONDITIONS
Brief Title
CAPER-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 75 years
- Diagnosis of acute coronary syndrome (including STEMI, NSTEMI, or unstable angina)
- Successful percutaneous coronary intervention with TIMI grade 3 flow and less than 30% residual stenosis
- Presence of atherosclerotic plaque in non-culprit coronary vessels
- Statin therapy received for at least 4 weeks with LDL-C 651.8 mmol/L or statin-naive with LDL-C 653.2 mmol/L
- Agreement to complete baseline coronary CT angiography and laboratory tests within 7 days of enrollment
- Signed informed consent and commitment to complete 52 weeks of follow-up
You will not qualify if you...
- History of coronary artery bypass grafting (CABG)
- History of valve surgery
- History of PCI treatment before the index acute coronary syndrome event
- Complex bifurcation lesions (Medina 1,1,1)
- Use of PCSK9 inhibitors or potent CYP3A4 inhibitors within the last 12 months
- Known intolerance to statins, evolocumab, or related investigational drugs
- Hepatic or renal insufficiency (eGFR <60 mL/min/1.73m8 or ALT/AST >3 times upper limit)
- Active autoimmune diseases (e.g., rheumatoid arthritis, lupus)
- Uncontrolled heart failure (NYHA class III-IV) or malignant arrhythmias
- Allergy or intolerance to contrast agents
- Pregnancy or breastfeeding or plans for pregnancy within next year
- Life expectancy less than 1 year due to advanced illness
- Participation in another interventional clinical trial within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive early evolocumab plus standard lipid-lowering therapy or standard lipid-lowering therapy alone after successful percutaneous coronary intervention for acute coronary syndrome, with treatment intended to reduce LDL cholesterol and evaluate coronary plaque progression.
2 visits for photon-counting coronary computed tomography angiography at baseline and 52 weeks
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xiaoyu Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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