The study will include 60 participants aged over 40 years with an established clinical diagnosis of stable CVD (ascertained by having either a previous diagnosis of myocardial infarction (MI), ischaemic stroke, peripheral vascular disease, evidence of occlusive coronary heart disease or a history of coronary, carotid or peripheral revascularisation). The inclusion and exclusion criteria are detailed in box 1. In summary, patients with a significant CV event within the prior 6 months to enrolment; uncontrolled type 2 diabetes mellitus; active malignancy; renal, hepatic thyroid or haematological dysfunction; and intolerance to statin therapy will be excluded from the study.

Patients with high-risk cardiovascular disease (CVD) with low-density lipoprotein cholesterol (LDL-C) of ≤4.0 mmol* OR patients with very high-risk CVD with LDL-C ≤3.5 mmol/L.†

Male or female patients over 40 years of age inclusive at screening, with a body weight ≥45 kg and BMI of ≥18 to ≤40 kg/m2.

History of stable CVD, defined as previous myocardial infarction (MI) (STEMI or NSTEMI), angioplasty, documented Coronary Artery Disease (stress echo, CT coronary angiography or invasive angiography), stroke, transient ischaemic attack or peripheral vascular disease without a recent event in the last 6 months (ie, acute coronary syndrome, unstable angina, coronary artery bypass grafting (CABG), Percutaneous Coronary Intervention (PCI), stroke, MI and carotid endarterectomy).

Uncontrolled hypertension blood pressure of >180/110 mm Hg on repeated measurements.

Fasting hypertriglyceridaemia with fasting triglyceride of >10 mmol/L at screening.

Pregnancy or combined contraceptive pill or hormone replacement therapy or childbearing potential.

Any concomitant condition that, at the discretion of the investigator, may affect the participant’s ability to complete the study.

Any known sensitivity to alirocumab or monoclonal antibodies.

Patients with history of hypersensitivity reactions to any of the study drugs.

History of significant LFTs (3×upper limit of normal (ULN) alanine transaminase or aspartate transaminase elevation) by previous statin treatment.

History of previous myositis associated with statin treatment (ie, myalgias or asymptomatic creatine kinase elevation>5×ULN).

Type 1 or type 2 diabetes, which is insulin dependent or on oral hypoglycaemics/diet with glycated haemoglobin (HbA1c) >8% (OR HbA1c >64 mmol/mol).

History of any acute cardiovascular (CV) event within 6 months prior to the screening period.

Rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (eg, inflammatory bowel disease).

Untreated hypothyroidism, known autoimmune myositis.

Patients with chronic kidney disease (defined as eGFR <30 mL/min/1.73 m2) at baseline will be excluded from the study.

Participant in a previous research study in the last 3 years which involved exposure to significant ionising radiation (ie, cumulative research radiation dose >5 mSv).

History of malignancy within the past 5 years (with the exception of localised carcinoma of the skin that has been resected for cure).

History of alcohol/drug abuse or dependence within 6 months of the study.

Use of systemic corticosteroids at the time of scanning.

Lack of ability to provide informed consent.

Treatment with medications that result in significant drug–drug interactions with study medications.

*High risk is defined as a history of any of the following: acute coronary syndrome, coronary or other arterial revascularisation procedures, chronic heart disease, ischaemic stroke and peripheral arterial disease.

†Very high risk is defined as recurrent CV events or CV events in more than one vascular bed (ie, polyvascular disease).

Note: The content above has been extracted from a research article, so it may not display correctly.



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