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A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy

NCT00401921 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-07-14

No results posted yet for this study

Summary

The primary aim of this protocol is to investigate a possible new, neuroprotective treatment to prevent cognitive deficits that occur after carotid endarterectomy. We will investigate whether a widely used antibiotic agent - minocycline - that has shown neuroprotective effects in animal models of neurological diseases - can reduce the cognitive deficits associated with the surgical procedure of carotid endarterectomy (CEA). Because these cognitive deficits are believed to be a result of small strokes (due to emboli and/or hypoperfusion), this study will provide preliminary data on the use of this drug as a neuroprotective agent in stroke - a leading cause of disability.

(1) The first aim of this study is to examine whether 5 doses of minocycline administered 36 hrs before and 1 dose 12 hrs after the surgical procedure in patients undergoing CEA are effective to reduce the cognitive deficits associated with this procedure as compared with placebo.

a. The null hypothesis is that there is no difference in cognitive performance changes after CEA between the patients that receive placebo or minocycline.

Conditions

  • Carotid Stenosis

Interventions

DRUG

Minocycline

100 mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery

DRUG

Placebo oral capsule

1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Robert Friedlander, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401921 on ClinicalTrials.gov