Atherosclerosis
Conditions
Interventions
Trade Name: Omalizumab (Xolair®)
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmac
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: (1) Patient is 18 years of age or older (2) Patient is able and willing to give their consent and sign an informed consent (3) Symptomatic or asymptomatic carotid artery stenosis based on atherosclerosis of at least 50% calculated by using criteria equivalent to the NASCET method (4) Revascularization through carotid endarterectomy is indicated by multidisciplinary panel Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: (1) Previous anaphylactic reaction (e.g. food allergy, medication such as antibiotics etc.) (2) Previous CEA or CAS in the ipsilateral artery (3) Patients with severe asthma or chronic urticaria which are treated or have been treated with omalizumab s.c.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is, to determine whether short term anti-IgE treatment with an anti-IgE monoclonal antibody (omalizumab) can limit intraplaque mast cell activation in atherosclerotic plaques.;Secondary Objective: Secondary objectives are to compare the following outcomes between the two treatment groups: (1) Local inflammatory status of atherosclerotic plaque (measuring T-cell subsets, M1/M2 macrophages, neutrophils and B-cells) (2) Plasma tryptase levels (3) Infection parameters (complete bloodcount, hsCRP, IL-1beta and IL-6) (4) Plaque characterization (e.g. necrotic area, cellular compostion and stability parameters) (5) Serum IgE levels (6) Basophil activation status ;Primary end point(s): The primary endpoint is activated mast cell as the percentage of the total mast cell (CD45+CD117+FceR+ cells) count, determined by flow cytometry. Normal unactivated mast cells are positive for the markers CD45, CD117 and FceR. In addition, activated mast cells are positive for IgE and the activationmarkers CD203c and CD63. The primary study parameter is the % of mast cell activation determined by flow cytometry.;Timepoint(s) of evaluation of this end point: The primary endpoint will be assesed in the atherosclerotic plaque which be collected during the carotid endarterectomy (+ 3 days after the administration of study medication). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are (endpoints will be compared between treatment groups and for point 2,3,5 and 6 between baseline and day 3): (1) Local inflammatory status of atherosclerotic plaque (measuring T-cell subsets, M1/M2 macrophages, neutrophils and B-cells counts) (2) Plasma tryptase levels (3) Level of infection parameters (complete blooudcount, hsCRP, IL-1beta and IL-6) (4) Plaque characterization (using histology) (5) Serum IgE levels (6) Basophil activation status ;Timepoint(s) of evaluation of this end point: Blood based secondary endpoints will be assesed with blood samples from baseline and 3 days after administration of study medication. Plaque based secondary endpoints will be assesed using the plaque which is acquired by carotid endarterectomy. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Vascular Surgery
UMC Utrecht
Outcome results
None listed