No registrations found.
ID
Source
Brief title
Health condition
Atherosclerotic vascular disease of the carotid artery
Sponsors and support
Amsterdam, the Netherlands
Intervention
Outcome measures
Primary outcome
After 3 weeks of treatment: Immunostaining for: CD3, CD4, CD8, CD40L, CD69, CD86.
Secondary outcome
After 3 weeks of treatment: Immunostaining for endothelial, plaque composition and stability markers
Background summary
Patients with carotid artery stenosis undergoing endarterectomy will be randomized to either placebo or MMF treatment. Prior to scheduled surgery baseline measurements will be assessed and patients will start study medication. One week prior to surgery a second study will take place and measurements will be repeated. At time of surgery endarterectomy specimens will be collected for immunostaining to evaluate T-cell and monocyte/macrophage numbers and activation status as well as effects on endothelial and smooth muscle cells on atherosclerotic plaque composition.
Study objective
T-cell inhibition with Mycophenolate Mofetil (MMF) attenuates T-cell number, T-cell activation and T-cell – monocyte interaction, thereby minimizing the T-cell-driven inflammatory amplification loop. The latter will contribute to improvement of anti-atherogenic defence mechanisms, such as improvement of endothelial function and attenuation of the pro-inflammatory state.
Intervention
Participants will be randomized to either treatment with mycophenolate mofetil (MMF) or placebo.
P.O. Box 22660
Sander Leuven, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5668675
s.i.vanleuven@amc.uva.nl
P.O. Box 22660
Sander Leuven, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5668675
s.i.vanleuven@amc.uva.nl
Inclusion criteria
Consecutive patients with carotid artery stenosis (>70% diameter stenosis on angiography or ultrasonography) with ipsilateral transient ischemic attack (TIA) who are planned to undergo carotid endarterectomy (CEA) will be included and treated for a minimum of three weeks prior to surgery. These patients will be recruited at the outpatient department of Vascular Surgery.
Exclusion criteria
Patients who are unable to tolerate MMF treatment, who withdraw their consent or those with any other medical condition or laboratory abnormality which in the opinion of the principal investigator could affect subject safety, preclude evaluation of response, or render unlikely that the patient would complete the study, are excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL828 |
| NTR-old | NTR841 |
| Other | : N/A |
| ISRCTN | ISRCTN84092396 |