RecruitingPhase 4

CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS

China233 participantsStarted 2026-05-19

Plain-language summary

The CAPRA-EVO trial is a single-center, randomized, open-label study with blinded endpoint assessment comparing early evolocumab plus standard lipid-lowering therapy versus standard-of-care lipid-lowering therapy in patients with acute coronary syndrome after successful percutaneous coronary intervention. The study will use serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to assess changes in non-culprit coronary plaque burden and stenosis severity. Secondary outcomes include changes in high-risk plaque features, lipid and inflammatory biomarkers, cardiovascular events, and safety outcomes. The trial aims to determine whether early intensive LDL-C lowering with evolocumab can reduce coronary plaque progression and support PCCT-CCTA as a noninvasive tool for monitoring atherosclerotic plaque dynamics.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Eligible patients must meet the following criteria: * Age between 40 and 75 years. * Diagnosis of ACS, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) or unstable angina (UA). * Successful PCI treatment, with post-procedural TIMI grade 3 flow and residual stenosis \<30% and atherosclerotic plaque presence in non-culprit coronary vessels (not attributed to this target event). * Suboptimal LDL-C control: Patients must have received any statin treatment for at least 4 weeks, with an LDL-C level ≥1.8 mmol/L; or Statin-naive patients must have an LDL-C level ≥3.2 mmol/L. * Agreement to complete baseline CCTA and laboratory tests within 7 days of enrollment and signed informed consent. * Commitment to complete 52 weeks of follow-up. Exclusion Criteria: * History of coronary artery bypass grafting (CABG). * History of valve surgery. * History of PCI treatment before the index ACS event * Complex bifurcation lesions (Medina 1,1,1). * Use of PCSK9 inhibitors (e.g., evolocumab, alirocumab) or potent CYP3A4 inhibitors (e.g., itraconazole) within the last 12 months. * Known intolerance to statins, evolocumab, or other investigational drugs related to the study. * Hepatic or renal insufficiency (eGFR \<60 mL/min/1.73m² or ALT/AST \>3 times the upper limit of normal). * Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus). * Uncontrolled heart failure (NYHA class III-IV) or mali…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically testing evolocumab started early after a heart attack or acute coronary syndrome — given my situation, does my doctor think starting this PCSK9 inhibitor early could be relevant for me, or would standard lipid-lowering therapy be a better first step?
2The trial is measuring how much plaque volume I have and how severe my artery narrowing is, including in high-risk areas like the left main coronary artery and the proximal LAD — does my doctor know whether I have disease in those specific locations, and would that make this trial particularly relevant or risky for me to discuss?
3Since this is a Phase 4 trial, evolocumab is already an approved medication — but what does my doctor think about the specific risks of the trial procedures used to measure plaque, like the serial imaging scans, compared to what I'd experience under standard care?
4The trial is still actively recruiting, which means it hasn't finished yet — how would joining this trial affect the timing of my regular treatment decisions, and would I have to delay or change anything I'm already scheduled to receive?
5The trial is looking at high-risk plaque features as part of what it measures — can my doctor explain whether my current imaging results suggest I have any of those features, and how that might factor into whether this trial is worth discussing further with my care team?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total atherosclerotic volume and stenosis severity

Timeframe: From enrollment to the end of treatment at 52 weeks

b. Stenosis severity at the target lesion level (defined as luminal stenosis ≥50%, particularly in left main coronary artery [LMCA] or proximal left anterior descending artery [LAD] OR presence of ≥2 high-risk plaque features)

Timeframe: From enrollment to the end of treatment at 52 weeks

Trial details

NCT IDNCT07612774

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Xiaoyu Wang

86+18384252874 wxy2cd@yeah.net

View on ClinicalTrials.gov More Coronary trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Total atherosclerotic volume and stenosis severity

Timeframe: From enrollment to the end of treatment at 52 weeks