AtherosclerosisPhase 1/2SILENCENCT01601106
Silencing Inflammatory Activity by Injecting Nanocort in Patients at Risk for Atherosclerotic Disease
A Phase 1/2 study testing liposomal prednisolone in people with Atherosclerosis and Inflammation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atherosclerosis, Inflammation
- What is being tested?
- liposomal prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to May 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Population with target to background ratio of 2.2 of the aorta or carotid artery on PET-CT
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, 1105AZ
Erik S Stroes, MD PhD, +31205665978, e.s.stroes@amc.uva.nl
Erik S Stroes, MD PhD
About this study
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
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.
- Conditions
- Atherosclerosis, Inflammation
- Being tested
- liposomal prednisolone, Placebo
- Keywords
- Atherosclerosis, inflammation
- Medical subject headings
- Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal prednisoloneDrug
Two weekly dosages with 150 mg.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Liposomal prednisolone | Active comparator | Not described Receives: Drug: liposomal prednisolone |
| Placebo control | Placebo comparator | Not described Receives: Drug: liposomal prednisolone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
18Fludeoxyglucose Positron emission computed tomography scan (18FDG PET-CT scan)
Measured: Day 8-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Erik S Stroes, MD PhD, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601106
- Sponsor's protocol ID
- NL37190.018.11
- Acronym
- SILENCE
- Status last verified
- May 2012
- First submitted
- 13 Oct 2011
- Last updated
- 21 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01601106
- Acronym / sponsor ID
- SILENCE / NL37190.018.11
- Conditions
- Atherosclerosis, Inflammation
- Keywords
- Atherosclerosis, inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (estimated)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal prednisolone | Active comparator | Drug: liposomal prednisolone |
| Placebo control | Placebo comparator | Drug: liposomal prednisolone, Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Population with target to background ratio of 2.2 of the aorta or carotid artery on PET-CT
Key exclusion criteria (16 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal prednisoloneTwo weekly dosages with 150 mg. | Drug | Liposomal prednisolone, Placebo control |
| Placebo | Drug | Placebo control |
Primary outcome
18Fludeoxyglucose Positron emission computed tomography scan (18FDG PET-CT scan)
Time frame: Day 8-13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik S Stroes, MD PhD principal investigator
AIDS Malignancy Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing liposomal prednisolone in people with Atherosclerosis and Inflammation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik S. Stroes, MD PhD (+31205665978, e.s.stroes@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18Fludeoxyglucose Positron emission computed tomography scan (18FDG PET-CT scan) (time frame: Day 8-13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2012.