| - candidate number | 2368 |
| - NTR Number | NTR841 |
| - ISRCTN | ISRCTN84092396 |
| - Date ISRCTN created | 16-jan-2007 |
| - date ISRCTN requested | 29-dec-2006 |
| - Date Registered NTR | 15-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | T-cell Inhibition by Mycophenolate Mofetil Treatment in Patients Undergoing Carotid Endarterectomy. |
| - Scientific Title | T-cell Inhibition by Mycophenolate Mofetil Treatment in Patients Undergoing Carotid Endarterectomy. |
| - ACRONYM | TimeToCare |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Vascular disease |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jun-2006 |
| - planned closingdate | 1-jan-2008 |
| - Target number of participants | 50 |
| - Interventions | Participants will be randomized to either treatment with mycophenolate mofetil (MMF) or placebo. |
| - 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 |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | MD. Sander Leuven, van |
| - CONTACT for SCIENTIFIC QUERIES | MD. Sander Leuven, van |
| - Sponsor/Initiator | Academic Medical Center (AMC) |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Department of Vascular Medicine |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 15-dec-2006 - 19-jan-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl