Condition category
Circulatory System
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
04/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) (The Netherlands)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20202636

Publication citations

  1. 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.

Additional files

Editorial Notes