Silencing Inflammatory Activity by Injecting Nanocort in Patients at Risk for Atherosclerotic Disease (SILENCE)
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis Inflammation | Drug: liposomal prednisolone Drug: Placebo | Phase 1 Phase 2 |
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 |
- 18Fludeoxyglucose Positron emission computed tomography scan (18FDG PET-CT scan) [ Time Frame: Day 8-13 ]

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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.
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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)

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 ClinicalTrials.gov identifier (NCT number): NCT01601106
Contact: Erik S. Stroes, MD PhD | +31205665978 | e.s.stroes@amc.uva.nl |
Netherlands | |
Academic Medical Center | Recruiting |
Amsterdam, Netherlands, 1105AZ | |
Contact: Erik S Stroes, MD PhD +31205665978 e.s.stroes@amc.uva.nl | |
Principal Investigator: Erik S Stroes, MD PhD |
Principal Investigator: | Erik S Stroes, MD PhD | AIDS Malignancy Consortium |
Responsible Party: | E.S.stroes, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov 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 |
Atherosclerosis, inflammation |
Atherosclerosis Inflammation Pathologic Processes Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Prednisolone |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |