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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR841 |
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Date of registration:
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15/12/2006 |
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Primary sponsor: |
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Public title:
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T-cell Inhibition by Mycophenolate Mofetil Treatment in Patients Undergoing Carotid Endarterectomy.
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Scientific title:
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T-cell Inhibition by Mycophenolate Mofetil Treatment in Patients Undergoing Carotid Endarterectomy. - TimeToCare |
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Date of first enrolment:
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1/6/2006 |
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Target sample size:
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50 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=841 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Sander
Leuven, van |
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Address:
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Academic Medical Center (AMC), Department of Vascular Medicine, room F4-159.2,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5668675 |
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Email:
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s.i.vanleuven@amc.uva.nl |
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Affiliation:
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Name:
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Sander
Leuven, van |
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Address:
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Academic Medical Center (AMC), Department of Vascular Medicine, room F4-159.2,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5668675 |
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Email:
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s.i.vanleuven@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Vascular disease
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Intervention(s)
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Participants will be randomized to either treatment with mycophenolate mofetil (MMF) or placebo.
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Primary Outcome(s)
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After 3 weeks of treatment: Immunostaining for: CD3, CD4, CD8, CD40L, CD69, CD86.
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Secondary Outcome(s)
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After 3 weeks of treatment: Immunostaining for endothelial, plaque composition and stability markers
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Secondary ID(s)
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ISRCTN84092396
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Vascular Medicine
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