PET Imaging of Inflammation and Lipid Lowering Study

Korábbi kezelés

• Treatment with medications that result in significant drug to drug interactions with the study medications
• Current use of systemic corticosteroids or other immunosuppressive drugs
• Previous or planned carotid endarterectomy surgery or stenting on the index side

Más betegség

• Sensitivity and/or contraindication to inclisiran or colchicine. Contraindications to colchicine include severe hepatic or renal impairment, blood disorders, and patients with renal or hepatic impairment who are taking a P-gp inhibitor or a strong CYP3A4 inhibitor
• Contrast allergy or contrast-nephropathy
• Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
• Uncontrolled chronic inflammatory disorder
• History of recent malignancy deemed relevant to the study by the investigator

Laborértékek

• Chronic kidney disease (eGFR <30 mL/min/1.73 m2)

Egyéb

• Women of childbearing potential not using adequate contraception
• Contra-indication to MRI scanning
• Statin-associated myositis or liver function abnormality
• Already taking inclisiran or colchicine
• Cardiovascular event within 6 months

• Male or female participants >18 years old
• Able to give written, informed consent and to lie flat
• Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia (HeFH) based on clinical criteria) or mixed dyslipidaemia, and
• History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral arterial disease) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies (see NICE TA 733), and
• Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and
• Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound