At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Inclisiran (drug), 68Ga-DOTATATE PET-MRI (diagnostic test), Colchicine (drug)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- Inclisiran — drug: Inclisiran 284 mg, one injection · 68Ga-DOTATATE PET-MRI — diagnostic test: 68Ga-DOTATATE PET-MRI at baseline and 12 weeks · Colchicine — drug: Colchicine 500 mcg tablet once daily
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 99 Years
- Who
- All
- Number of participants
- 63
- Started
- 2023-03-20
- Last checked
- 2024-07
Plain English Summary
What is this study?
- • Testing a new treatment for hypercholesterolemia
- • NA - 63 participants
- • 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
Who can take part?
- • Ages 18 Years to 99 Years
- • Diagnosed with hypercholesterolemia
Where?
- • Cambridge - University of Cambridge
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.
More detail
Up-regulation of SST2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68Ga-DOTATATE. To test the hypothesis that 68Ga-DOTATATE can quantify drug-induced changes in arterial inflammation, patients with primary hypercholesterolaemia (non-familial or familial) or mixed dyslipidaemia with stable cardiovascular Disease (CVD) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies will undergo carotid artery 68Ga-DOTATATE PET-magnetic resonance imaging (MRI) in a randomised, double-blind, placebo-controlled study of inclisiran or colchicine. In parallel, we will examine a novel method for detecting plaque composition based on analysis of ultrasound centre frequency shifts, which was developed by collaborators in Lund University, Sweden. The Ultrasound Plaque Structure Analysis (UPSA) method uses radiofrequency algorithms to create real-time tissue-like maps of carotid plaques. Participants in the study will undergo carotid ultrasound imaging using the UPSA method in addition to PET/MRI.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 99 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male or female participants \>18 years old
- ✓Able to give written, agreement to take part and to lie flat
- ✓Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia...
- ✓Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and
- ✓Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound
Who cannot take part
- ✗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
- ✗Contrast allergy or contrast-nephropathy
See the full criteria
Where Is This Study? (1 UK site)
University of Cambridge
Cambridge, United Kingdom
How to Get in Touch
Jason M Tarkin, MBBS PhD
Sponsor contactCONTACT
