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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01601106
Recruitment Status : Unknown
Verified May 2012 by E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : May 17, 2012
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):
E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
Cardiovascular disease(CVD) is the leading cause of morbidity and mortality in developed nations. CVD is primarily caused by atherosclerosis, a systemic disease characterized by lipid deposition in the subendothelial space with a concomitant, low-grade inflammatory reaction.(Fuster, Moreno et al. 2005) To date, most therapeutic interventions aimed at lowering CVD have thus far focused on modulating lipid levels, either lowering LDLc or increasing HDLc levels. Yet, since the introduction of statins 20 years ago, there have been few breakthroughs in the treatment of this disease. A promising strategy to reduce CVD is to directly target inflammation at the level of the vessel wall.(van Leuven, van Wijk et al.; Libby 2002) A potential drawback of anti-inflammatory strategies pertains to the thin line between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. Therefore, continuous low dosed anti-inflammatory drugs have great potential as novel treatment strategies. In the present project, the investigators propose to inject liposomal glucocorticoids intravenously in patients with an increased risk of atherosclerotic disease aiming to reduce vessel wall inflammation.

Condition or disease Intervention/treatment Phase
Atherosclerosis Inflammation Drug: liposomal prednisolone Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Estimated Primary Completion Date : May 2013

Arm Intervention/treatment
Active Comparator: Liposomal prednisolone Drug: liposomal prednisolone
Two weekly dosages with 150 mg.

Placebo Comparator: Placebo control Drug: liposomal prednisolone
Two weekly dosages with 150 mg.

Drug: Placebo

Primary Outcome Measures :
  1. 18Fludeoxyglucose Positron emission computed tomography scan (18FDG PET-CT scan) [ Time Frame: Day 8-13 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01601106

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Contact: Erik S. Stroes, MD PhD +31205665978

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Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Erik S Stroes, MD PhD    +31205665978   
Principal Investigator: Erik S Stroes, MD PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Principal Investigator: Erik S Stroes, MD PhD AIDS Malignancy Consortium
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Responsible Party: E.S.stroes, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier: NCT01601106    
Other Study ID Numbers: NL37190.018.11
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012
Keywords provided by E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Atherosclerosis, inflammation
Additional relevant MeSH terms:
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Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents