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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21023
Enrollment
50
Registered
2006-12-15
Start date
2006-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic vascular disease of the carotid artery

Interventions

Participants will be randomized to either treatment with mycophenolate mofetil (MMF) or placebo.

Sponsors

Academic Medical Center Amsterdam, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
After 3 weeks of treatment: Immunostaining for: CD3, CD4, CD8, CD40L, CD69, CD86.

Secondary

MeasureTime frame
After 3 weeks of treatment: Immunostaining for endothelial, plaque composition and stability markers

Contacts

Public ContactSander Leuven, van

Academic Medical Center (AMC), Department of Vascular Medicine, room F4-159.2, P.O. Box 22660

s.i.vanleuven@amc.uva.nl+31 (0)20 5668675

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)