Evaluation of the subcutaneous administration of 30 mg of S78989 versus placebo and evaluation of the subcutaneous administration of 60mg of S78989 versus placebo, on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation. A 28-weeks, randomized, double-blind, parallel-group, placebo controlled, international multicenter exploratory pilot study.
- Conditions
- arterial wall inflammationartherosclerosis10003216
- Registration Number
- NL-OMON39440
- Lead Sponsor
- I.R.I.S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
Main selection criteria:
* Male or female of non-childbearing potential (contraception allowed), aged over 50 years with a documented recent (3-12 months) acute coronary syndrome (ACS) defined as the association of a chest pain episode or its equivalent and either:
o elevated troponin
o Percutaneous Coronary Intervention (PCI) performed because of the related ACS event
o significant coronary stenosis (visual assessment before any percutaneous dilatation) diagnosed in at least one native vessel on a coronary angiography performed after the event.
* Informed consent signed
* All revascularization procedures planned after the acute event, completed at least 3 months before selection visit
* Use of statins since at least 3 months before selection, and no change in use of any antidyslipidemic treatment within the 2 months prior to selection en between selection and inclusion.
Main inclusion criteria
* Patients with a maximum mean Target to Background Ratio (TBR), measured by 18-FDG PET/CT in any region of interest (left carotid, right carotid, thoracic aorta) > 1.8 at selection visit.
Main-non selection/non-inclusion
*Pregnancy
*Type I diabetes or uncontrolled diabetes (HBA1c>9.5%),
*History of heart surgery (including coronary artery bypass graft surgery) within 1 year prior to selection,
*Chronic inflammatory diseases,
*History or symptoms of demyelinating disease
*History of malignancy within 3 years other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin,
*Recent or active infectious diseases,
*Chronic infectious diseases including active tuberculosis, HIV and hepatitis B or C,
*Known immunodeficiency,
*Use of:
-Corticosteroids (>20mg/day of prednisolone or equivalent within 1 month previous selection)
-Biologic or immunosuppressive therapy within 3 months previous selection
-Live vaccine within 3 months prior to selection (with the exception of live seasonal flu and live HN1 vaccins that are permitted until 2 weeks before inclusion).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The changes from baseline mean of the maximum TBR, average mean TBR, mean of<br /><br>max TBR and maximum max TBR assessed by 18F-FDG PET/CT. </p><br>
- Secondary Outcome Measures
Name Time Method