Silencing Inflammatory Activity by Injecting Nanocort in Patients at Risk for Atherosclerotic Disease (SILENCE)

This is an interventional treatment trial for Atherosclerosis focused on measuring Atherosclerosis, inflammation Read More

Inclusion Criteria:

• Population with target to background ratio of 2.2 of the aorta or carotid artery on PET-CT

Exclusion Criteria:

• Current medical history of auto-immune disease/vasculitis, active inflammatory diseases, Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy.

• Recent or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including but not limited to:

  • Steroids for at least 6 weeks prior to baseline measurement and during study (with the exception of inhaled acute use steroids).
  • Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex. Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study
  • No other disease modifying antirheumatic drugs (DMRADS) within 6 weeks of baseline and during study (such as cyclosporine, azatioprine, etc.)
• Known systemic disorders such as hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study.
• Changes in dose or frequency of doses at least 6 weeks prior to baseline measurement (unstable dosing) in angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, nonsteroidal anti-inflammatory drugs (NSAIDS), and cyclo-oxygenase-2 inhibitors (COXIBs)
• Standard contra-indications to MRI, 18FDG PET, and CT based on physicians experience and current practices
• Current medical history of poorly controlled diabetes defined as hemoglobin A1c (HbA1c) >7.5%.
• Current medical history of drug or alcohol abuse within 12 months prior to screening.
• History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
• Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
• Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.
• Use of any investigational drug in the 3 months prior to study drug administration.
• Use of insulin or any oral anti-diabetic (except metformin) in the 30 days prior to baseline measurements. Those subjects who are taking metformin may be included in the study if they are on a stable dose for at least 4 weeks and have a HbA1c <7.5%.
• Any contraindications for corticosteroid infusions (for example, but not limited current infections or vaccinations)