T-cell Inhibition by Mycophenolate Mofetil Treatment in Patients Undergoing Carotid Endarterectomy

ISRCTN	ISRCTN84092396
DOI	https://doi.org/10.1186/ISRCTN84092396
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sander van Leuven
Scientific

Academic Medical Center (AMC)
Department of Vascular Medicine
Room F4-159.2
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 8675
Email	s.i.vanleuven@amc.uva.nl

Study design	Randomised, placebo controlled, parallel group, double blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Time To Care
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Vascular disease
Intervention	Participants will be randomised to either treatment with mycophenolate mofetil (MMF) or placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/06/2006
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	50
Key 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.
Key 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.
Date of first enrolment	01/06/2006
Date of final enrolment	01/01/2008

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No