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A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma

ConditionsCoronary Artery DiseaseHypercholesterolemiaAtheromaAtherosclerotic Plaque
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmgen

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 m²) 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Evolocumab

    Drug

    Evolocumab will be provided as a single-dose, prefilled AI pen for fixed dose subcutaneous (SC) injection.

  • Routine Lipid Management

    Drug

    Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

  • Autoinjector

    Device

    AI for SC injection of Evolocumab

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: Evolocumab and Routine Lipid ManagementExperimental treatment 3 interventions
Group B: Routine Lipid ManagementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Non-Calcified Plaque (NCP) Volume from Baseline to Week 72

Time frame
From Baseline to Week 72

Secondary outcomes

1

Change From Baseline in Low Attenuation Plaque Volume

Time frame
From Baseline to Week 72
2

Change From Baseline in Total Plaque Volume

Time frame
From Baseline to Week 72
3

Change From Baseline in Calcified Plaque Volume

Time frame
From Baseline to Week 72
4

Change From Baseline in Lumen Volume

Time frame
From Baseline to Week 72

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: