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A Phase I/II, Single-Center, Randomized, Placebo-Controlled Study Evaluating the Therapeutic Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) in Subjects With Severe Inflamed Carotid or Aortic Atherosclerosis Plaques


Phase 1/Phase 2
50 Years
N/A
Open (Enrolling)
Both
Atherosclerosis, Inflammation

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Trial Information

A Phase I/II, Single-Center, Randomized, Placebo-Controlled Study Evaluating the Therapeutic Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) in Subjects With Severe Inflamed Carotid or Aortic Atherosclerosis Plaques


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

18Fludeoxyglucose Positron emission computed tomography scan (18FDG PET-CT scan)

Outcome Time Frame:

Day 8-13

Safety Issue:

No

Principal Investigator

Erik S Stroes, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AIDS Malignancy Clinical Trials Consortium

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NL37190.018.11

NCT ID:

NCT01601106

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Atherosclerosis
  • Inflammation
  • Atherosclerosis, inflammation
  • Atherosclerosis
  • Inflammation

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