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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total atherosclerotic volume and stenosis severity | a. Total atherosclerotic volume (TAV) at the whole-non-culprit-vessel level: Change from baseline CTA (week 0) to endpoint CTA(week 52). | 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) | From enrollment to the end of treatment at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HRP change | Change in high-risk plaque (HRP) features from baseline CTA (week 0) to endpoint CTA (week 52). | From enrollment to the end of treatment at 52 weeks |
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Inclusion Criteria:
Eligible patients must meet the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Wang | Contact | 86+18384252874 | wxy2cd@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Yong He | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
IPD that will be shared include anonymized data on baseline characteristics, primary and secondary outcome measures.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| C566337 | Hypercholesterolemia, Autosomal Dominant, 3 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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| Serial photon-counting coronary computed tomography angiography | Diagnostic 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 Therapy | Drug | Participants will receive guideline-directed standard lipid-lowering therapy according to contemporary clinical practice and investigator judgment. |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |