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New treatment option for Hypercholesterolemia
Official title PET Imaging of Inflammation and Lipid Lowering Study
ClinicalTrials.gov ID: NCT04073797
What this study is testing
What is Inclisiran?
Inclisiran is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hypercholesterolemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral...
- Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and
You likely can't join if
- 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
- Sensitivity and/or contraindication to inclisiran or colchicine. Contraindications to colchicine include severe hepatic or renal impairment, blood...
- Contrast allergy or contrast-nephropathy
See the full eligibility criteria
- 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...
- Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and
- Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound
- 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
- 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...
- Contrast allergy or contrast-nephropathy
- Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
- Cardiovascular event within 6 months
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.