NCT07612774RecruitingPhase 4
CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
A Multicenter, Randomized Controlled Comparison of Effect of Evolocumab Versus Standard Lipid Lowering Therapy on Plaque Progression in Patients With Acute Coronary Syndrome by Serial PCCT (CAPRA-EVO Trial)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 18 May 2026
- Start date
- 19 Nov 2025
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- West China Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07612774
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 232
- From 19 Nov 2025 to the primary completion date, 31 Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of coronary artery bypass grafting (CABG).
- History of valve surgery.
- History of PCI treatment before the index ACS event
- Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- Uncontrolled heart failure (NYHA class III-IV) or malignant arrhythmias.
- Known allergy or hypersensitivity to iodinated contrast media
- Hyperthyroidism or active thyroid disease
- Life expectancy of less than 1 year (e.g., due to advanced malignancy).
Lab values
- Hepatic or renal insufficiency (eGFR \<60 mL/min/1.73m² or ALT/AST \>3 times the upper limit of normal).
Other
- Complex bifurcation lesions (Medina 1,1,1).
- Pregnancy or breastfeeding (or plans for pregnancy within the next year).
- Participation in another interventional clinical trial within the past 3 months.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Tangdu Hospital, Air Force Medical University Coordinator of this site? Confirm its status | Xi'an | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.