Contact information
Type
Scientific
Primary contact
Dr Sander van Leuven
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Vascular Medicine
Room F4-159.2
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 8675
s.i.vanleuven@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Time To Care
Study hypothesis
T-cell inhibition with Mycophenolate Mofetil (MMF) attenuates T-cell number, T-cell activation and T-cell monocyte interaction, thereby minimising 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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Vascular disease
Intervention
Participants will be randomised to either treatment with mycophenolate mofetil (MMF) or placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Mycophenolate mofetil (MMF)
Primary outcome measure
After three weeks of treatment: immunostaining for: CD3, CD4, CD8, CD40L, CD69, CD86.
Secondary outcome measures
After three weeks of treatment: immunostaining for endothelial, plaque composition and stability markers.
Overall trial start date
01/06/2006
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Consecutive patients with carotid artery stenosis (more than 70% diameter stenosis on angiography or ultrasonography) with ipsilateral Transient Ischaemic 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant 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.
Recruitment start date
01/06/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20202636
Publication citations
-
Results
van Leuven SI, van Wijk DF, Volger OL, de Vries JP, van der Loos CM, de Kleijn DV, Horrevoets AJ, Tak PP, van der Wal AC, de Boer OJ, Pasterkamp G, Hayden MR, Kastelein JJ, Stroes ES, Mycophenolate mofetil attenuates plaque inflammation in patients with symptomatic carotid artery stenosis., Atherosclerosis, 2010, 211, 1, 231-236, doi: 10.1016/j.atherosclerosis.2010.01.043.