PET Imaging of Inflammation and Lipid Lowering Study

Sponsor
University of Cambridge
Study ID
NCT04073797
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 20, 2023
Status verified
Jul 2024
Primary completion
Oct 1, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Stable CVD - treatment
    Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to add on therapy with inclisiran + placebo tablet
  • Active Comparator: Stable CVD - placebo control
    Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to placebo injection + colchicine tablet
  • Placebo Comparator: HeFH - treatment
    Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to placebo injection + placebo tablet

Primary Outcome Measure

Carotid 68Ga-DOTATATE PET [ Time Frame: 12 weeks ]

Central Contacts

Related Studies