CoronaryPhase 4CAPRA-EVONCT07612774
CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
A Phase 4 study testing Evolocumab, Serial photon-counting coronary computed tomography angiography and Standard Lipid-Lowering Therapy in people with Coronary and Coronary Artery Disease, run by West China Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary, Coronary Artery Disease
- What is being tested?
- Evolocumab, Serial photon-counting coronary computed tomography angiography and Standard Lipid-Lowering Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesChina
- Study dates
- 19 Nov 2025to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 malignant arrhythmias.
- Known allergy or hypersensitivity to iodinated contrast media
- Hyperthyroidism or active thyroid disease
- Pregnancy or breastfeeding (or plans for pregnancy within the next year).
- Life expectancy of less than 1 year (e.g., due to advanced malignancy).
- Participation in another interventional clinical trial within the past 3 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Not yet recruiting
Tangdu Hospital, Air Force Medical University
Xi’an, Shanxi
Yan Li
About this study
Official title: 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)
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.
- Conditions
- Coronary, Coronary Artery Disease
- Being tested
- Evolocumab, Serial photon-counting coronary computed tomography angiography, Standard Lipid-Lowering Therapy
- Keywords
- acute coronary syndrome, coronary computed tomography angiography, proprotein convertase subtilisin/kexin type 9, randomized controlled trial
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Hypercholesterolemia, Autosomal Dominant, 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Evolocumab will be administered early after randomization in participants assigned to the experimental arm, in addition to standard-of-care lipid-lowering therapy. The treatment is intended to achieve intensive low-density lipoprotein cholesterol reduction and to evaluate its effect on coronary plaque progression or stabilization over 52 weeks.
Serial photon-counting coronary computed tomography angiographyDiagnostic test
All participants will undergo photon-counting coronary computed tomography angiography at baseline and at 52 weeks. Imaging will be used to assess changes in total atherosclerotic volume, stenosis severity, and high-risk plaque features in non-culprit coronary vessels.
Standard Lipid-Lowering TherapyDrug
Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy | Experimental | Participants randomized to this arm will receive early evolocumab in addition to standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features. Receives: Drug: Evolocumab; Diagnostic Test: Serial photon-counting coronary computed tomography angiography |
| Active Comparator: Standard Lipid-Lowering Therapy | Active comparator | Participants randomized to this arm will receive guideline-directed standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features. Receives: Diagnostic Test: Serial photon-counting coronary computed tomography angiography; Drug: Standard Lipid-Lowering Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total atherosclerotic volume and stenosis severity
- Total atherosclerotic volume (TAV) at the whole-non-culprit-vessel level: Change from baseline CTA (week 0) to endpoint CTA(week 52).
Measured: 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)
Measured: From enrollment to the end of treatment at 52 weeks
Secondary outcomes (1)
HRP change
Change in high-risk plaque (HRP) features from baseline CTA (week 0) to endpoint CTA (week 52).
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start19 Nov 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronaryStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, West China Hospital
- Investigators
- Yong He, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612774
- Sponsor's protocol ID
- WestChinaH-CVD-010
- Acronym
- CAPRA-EVO
- Status last verified
- Oct 2026
- First submitted
- 18 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07612774
- Acronym / sponsor ID
- CAPRA-EVO / WestChinaH-CVD-010
- Conditions
- Coronary, Coronary Artery Disease
- Keywords
- acute coronary syndrome, coronary computed tomography angiography, proprotein convertase subtilisin/kexin type 9, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy | Experimental | Drug: Evolocumab, Diagnostic Test: Serial photon-counting coronary computed tomography angiographyParticipants randomized to this arm will receive early evolocumab in addition to standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features. |
| Active Comparator: Standard Lipid-Lowering Therapy | Active comparator | Diagnostic Test: Serial photon-counting coronary computed tomography angiography, Drug: Standard Lipid-Lowering TherapyParticipants randomized to this arm will receive guideline-directed standard-of-care lipid-lowering therapy after successful percutaneous coronary intervention for acute coronary syndrome. Participants will undergo serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to evaluate changes in non-culprit coronary plaque burden, stenosis severity, and high-risk plaque features. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabEvolocumab will be administered early after randomization in participants assigned to the experimental arm, in addition to standard-of-care lipid-lowering therapy. The treatment is intended to achieve intensive low-density lipoprotein cholesterol reduction and to evaluate its effect on coronary plaque progression or stabilization over 52 weeks. | Drug | Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy |
| Serial photon-counting coronary computed tomography angiographyAll participants will undergo photon-counting coronary computed tomography angiography at baseline and at 52 weeks. Imaging will be used to assess changes in total atherosclerotic volume, stenosis severity, and high-risk plaque features in non-culprit coronary vessels. | Diagnostic test | Active Comparator: Standard Lipid-Lowering Therapy, Experimental: Evolocumab Plus Standard Lipid-Lowering Therapy |
| Standard Lipid-Lowering TherapyParticipants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment. | Drug | Active Comparator: Standard Lipid-Lowering Therapy |
Primary outcome
Total atherosclerotic volume and stenosis severity
Time frame: From enrollment to the end of treatment at 52 weeks
a. Total atherosclerotic volume (TAV) at the whole-non-culprit-vessel level: Change from baseline CTA (week 0) to endpoint CTA(week 52).
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)
Time frame: From enrollment to the end of treatment at 52 weeks
1 secondary outcome
HRP change
Time frame: From enrollment to the end of treatment at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong He study director
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab, Serial photon-counting coronary computed tomography angiography and Standard Lipid-Lowering Therapy in people with Coronary and Coronary Artery Disease, run by West China Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Wang (86+18384252874, wxy2cd@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total atherosclerotic volume and stenosis severity (time frame: From enrollment to the end of treatment at 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.