Coronary Artery DiseasePhase 4NCT07803679
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
A Phase 4 study testing Evolocumab, Routine Lipid Management and Autoinjector in people with Coronary Artery Disease and Hypercholesterolemia, run by Amgen.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Hypercholesterolemia, Atheroma
- What is being tested?
- Evolocumab, Routine Lipid Management and Autoinjector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2027to 30 Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At screening, one of the two following conditions must be met: Evidence of established CAD as demonstrated by: Prior non-invasive imaging modality that demonstrates at least one major epicardial vessel with mild-to-moderate obstruction (Coronary Artery Disease Reporting and Data System (CAD-RADS) 1-3) OR Presence of an abnormal coronary artery calcium (CAC) score > 50 OR Positive stress test indicative of suspected CAD OR Presumed CAD as determined by presence of at least one of the following conditions: Known history of diabetes mellitus (DM; type 1 or 2) with at least one of the following: DM requiring insulin therapy OR DM disease onset ≥ 5 years ago OR DM with evidence of end-organ damage such as diabetic retinopathy, neuropathy, or nephropathy OR Known history of peripheral artery disease due to atherosclerosis or carotid artery atheroma.
- Low-density Lipoprotein cholesterol (LDL-C) of at least 70 milligrams per deciliter (mg/dL).
- Patients with Intermediate pre-test probability of obstructive coronary artery lesions.
- Minimal total plaque volume (TPV) of 100 cubic millimeters (mm^3) measured during baseline AI-QCPA.
- Must be on stable lipid-lowering therapy for at least 6 weeks, with no planned changes and no plans to initiate Proprotein Convertase Subtilisin/Kexin type 9 ( PCSK9) inhibition.
Who cannot join
- Lifetime history of myocardial infarction (MI), ischemic stroke, or coronary revascularization.
- Symptomatic coronary artery disease or stable chronic coronary artery disease that, in the opinion of the investigator, meets criteria for urgent or elective revascularization procedures (coronary artery bypass grafting or percutaneous coronary intervention).
- Planned cardiac surgery, arterial revascularization, or planned major non-cardiac surgery during the study period.
- Contraindication to performing serial CCTA imaging such as: Severe renal insufficiency (estimated Glomerular Filtration Rate (eGFR) < 30 milliliters per minute per 1.73 square meters (30 mL/min/1.73 m^2) History of hypersensitivity to iodinated contrast Body weight and/or body circumference that prevent safe and successful Computed Tomography (CT) imaging, in the opinion of the investigator; Other patient-related factors that may interfere with diagnostic quality of CCTA images including: Atrial fibrillation Heart rate >60-70 beats per minute; Tachycardia or significant arrhythmia that cannot be adequately controlled with medications to allow CCTA Irregular rhythm (including Premature Ventricular Contraction (PVCs)); Inability to sustain a breath hold for at least five seconds.
- Prior history of PCSK9 inhibitor treatment within the past 12 months or known lifetime discontinuation of prior PCSK9 inhibitor due to adverse reaction, lack of tolerability, or lack of treatment response.
- History or evidence of any other clinically significant disorder, condition (including incidental CCTA findings), or disease that, in the opinion of the investigator, would pose a risk to participant safety.
- CCTA showing any of the following: Total occlusion OR Lesion-specific FFRct value ≤ 0.80 OR Diameter stenosis of the left main coronary artery >50 % OR Diameter stenosis of all three major coronary arteries >50%.
- CCTA not meeting established imaging criteria after two attempts during the baseline CCTA visit as assessed by the central imaging laboratory.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 4, Open-label, Blinded Primary Endpoint, Randomized Multicenter Trial to Assess the Effectiveness of Evolocumab With Routine Lipid Management Compared With Routine Lipid Management Alone in Reducing the Plaque Burden in Patients With Subclinical Atheroma
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).
Read the detailed description
HeartFlow is the imaging vendor
- Being tested
- Evolocumab, Routine Lipid Management, Autoinjector
- Keywords
- Pragmatic trial, Open-label, Coronary Computed Tomography Angiography (CCTA), AI-enabled Quantitative Coronary Plaque Analysis (AI-QCPA), Evolocumab, Routine lipid management, Stable coronary artery disease (CAD), Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor, Non-calcified plaque (NCP)
- Medical subject headings
- Coronary Artery Disease, Hypercholesterolemia, Plaque, Atherosclerotic, Hypercholesterolemia, Autosomal Dominant, 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called AMG 145, Repatha
Evolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection.
Routine Lipid ManagementDrug
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
AutoinjectorDevice
AI for SC injection of Evolocumab
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab and Routine Lipid Management | Experimental | Participants will receive Evolocumab via Autoinjector (AI) every 2 weeks (Q2W) plus routine lipid management. Receives: Drug: Evolocumab; Drug: Routine Lipid Management; Device: Autoinjector |
| Routine Lipid Management | Active comparator | Participants will receive routine lipid management per standard of care (SoC). Receives: Drug: Routine Lipid Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72
Measured: From Baseline to Week 72
Secondary outcomes (5)
Change From Baseline in Low Attenuation Plaque Volume
Measured: From Baseline to Week 72
Change From Baseline in Total Plaque Volume
Measured: From Baseline to Week 72
Change From Baseline in Calcified Plaque Volume
Measured: From Baseline to Week 72
Change From Baseline in Lumen Volume
Measured: From Baseline to Week 72
Change From Baseline in Lesion-specific and nadir Coronary Computed Tomography Angiography (CCTA) derived Fractional Flow Reserve (FFRct)
Measured: From Baseline to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start31 Jan 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803679
- Sponsor's protocol ID
- 20250101
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-label, Blinded Primary Endpoint, Randomized Multicenter Trial to Assess the Effectiveness of Evolocumab With Routine Lipid Management Compared With Routine Lipid Management Alone in Reducing the Plaque Burden in Patients With Subclinical Atheroma
- ClinicalTrials.gov ID
- NCT07803679
- Acronym / sponsor ID
- 20250101
- Keywords
- Pragmatic trial, Open-label, Coronary Computed Tomography Angiography (CCTA), AI-enabled Quantitative Coronary Plaque Analysis (AI-QCPA), Evolocumab, Routine lipid management, Stable coronary artery disease (CAD), Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Sep 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 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).
Detailed description
HeartFlow is the imaging vendor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolocumab and Routine Lipid Management | Experimental | Drug: Evolocumab, Drug: Routine Lipid Management, Device: AutoinjectorParticipants will receive Evolocumab via Autoinjector (AI) every 2 weeks (Q2W) plus routine lipid management. |
| Routine Lipid Management | Active comparator | Drug: Routine Lipid ManagementParticipants will receive routine lipid management per standard of care (SoC). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At screening, one of the two following conditions must be met: Evidence of established CAD as demonstrated by: Prior non-invasive imaging modality that demonstrates at least one major epicardial vessel with mild-to-moderate obstruction (Coronary Artery Disease Reporting and Data System (CAD-RADS) 1-3) OR Presence of an abnormal coronary artery calcium (CAC) score > 50 OR Positive stress test indicative of suspected CAD OR Presumed CAD as determined by presence of at least one of the following conditions: Known history of diabetes mellitus (DM; type 1 or 2) with at least one of the following: DM requiring insulin therapy OR DM disease onset ≥ 5 years ago OR DM with evidence of end-organ damage such as diabetic retinopathy, neuropathy, or nephropathy OR Known history of peripheral artery disease due to atherosclerosis or carotid artery atheroma.
- Low-density Lipoprotein cholesterol (LDL-C) of at least 70 milligrams per deciliter (mg/dL).
- Patients with Intermediate pre-test probability of obstructive coronary artery lesions.
- Minimal total plaque volume (TPV) of 100 cubic millimeters (mm^3) measured during baseline AI-QCPA.
- Must be on stable lipid-lowering therapy for at least 6 weeks, with no planned changes and no plans to initiate Proprotein Convertase Subtilisin/Kexin type 9 ( PCSK9) inhibition.
Key exclusion criteria (8 listed)
- Lifetime history of myocardial infarction (MI), ischemic stroke, or coronary revascularization.
- Symptomatic coronary artery disease or stable chronic coronary artery disease that, in the opinion of the investigator, meets criteria for urgent or elective revascularization procedures (coronary artery bypass grafting or percutaneous coronary intervention).
- Planned cardiac surgery, arterial revascularization, or planned major non-cardiac surgery during the study period.
- Contraindication to performing serial CCTA imaging such as: Severe renal insufficiency (estimated Glomerular Filtration Rate (eGFR) < 30 milliliters per minute per 1.73 square meters (30 mL/min/1.73 m^2) History of hypersensitivity to iodinated contrast Body weight and/or body circumference that prevent safe and successful Computed Tomography (CT) imaging, in the opinion of the investigator; Other patient-related factors that may interfere with diagnostic quality of CCTA images including: Atrial fibrillation Heart rate >60-70 beats per minute; Tachycardia or significant arrhythmia that cannot be adequately controlled with medications to allow CCTA Irregular rhythm (including Premature Ventricular Contraction (PVCs)); Inability to sustain a breath hold for at least five seconds.
- Prior history of PCSK9 inhibitor treatment within the past 12 months or known lifetime discontinuation of prior PCSK9 inhibitor due to adverse reaction, lack of tolerability, or lack of treatment response.
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 |
|---|---|---|
| EvolocumabAlso: AMG 145, RepathaEvolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection. | Drug | Evolocumab and Routine Lipid Management |
| Routine Lipid ManagementRoutine lipid management therapies will be administered at the discretion of the investigator per SoC. | Drug | Evolocumab and Routine Lipid Management, Routine Lipid Management |
| AutoinjectorAI for SC injection of Evolocumab | Device | Evolocumab and Routine Lipid Management |
Primary outcome
Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72
Time frame: From Baseline to Week 72
5 secondary outcomes
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
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 21 Sep 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab, Routine Lipid Management and Autoinjector in people with Coronary Artery Disease and Hypercholesterolemia, run by Amgen.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72 (time frame: From Baseline to Week 72). 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 21 Sep 2026.