A Phase 4 interventional study of Evolocumab and Routine Lipid Management in Coronary Artery Disease, Hypercholesterolemia and Atheroma, sponsored by Amgen. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Amgen · Phase 4, Interventional, and Treatment
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled Quantitative Coronary Plaque Analysis (AI-QCPA) from Coronary Computed Tomography Angiography (CCTA).
HeartFlow is the imaging vendor
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 308 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Evolocumab via Autoinjector (AI) every 2 weeks (Q2W) plus routine lipid management.
Drug: Evolocumab · Drug: Routine Lipid Management · Device: Autoinjector
Participants will receive routine lipid management per standard of care (SoC).
Drug: Routine Lipid Management
Evolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection.
Also known as: AMG 145, Repatha
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
AI for SC injection of Evolocumab
Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72
Time frame: From Baseline to Week 72
Change From Baseline in Low Attenuation Plaque Volume
Time frame: From Baseline to Week 72
Change From Baseline in Total Plaque Volume
Time frame: From Baseline to Week 72
Change From Baseline in Calcified Plaque Volume
Time frame: From Baseline to Week 72
Change From Baseline in Lumen Volume
Time frame: From Baseline to Week 72
Change From Baseline in Lesion-specific and nadir Coronary Computed Tomography Angiography (CCTA) derived Fractional Flow Reserve (FFRct)
Time frame: From Baseline to Week 72
No study locations are listed for this record.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Start is estimated for Jan 2027; primary completion for Apr 2029, 26 months later.
Of 193 phase 4 interventional studies under Coronary Artery Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's planned 26 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Evolocumab