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The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization

NCT02178813 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-06-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline in the patient population undergoing carotid revascularization procedures, namely carotid endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will facilitate proceeding to a phase II trial.

During this trial, patients undergoing carotid revascularization procedures will receive high doses of minocycline with the following schedule (based on previous trials):

* Day prior to procedure: 800mg orally (p.o), 700mg p.o.
* Day of procedure: 600mg intravenously( i.v.), 500mg p.o.
* Day after procedure: 400mg p.o., 400mg p.o.

The levels of the drug in the plasma, standard blood tests (complete blood count, creatinine, liver function tests) as well as markers of neuronal injury (Neuron specific enolase, protein- S100b) and inflammation (C-reactive protein) will also be monitored. The patients will be monitored closely for the development of side effects from minocycline.

MRI imaging will be used to follow the development of small strokes as a result of the revascularization procedures and their resolution. The patients of this study, all receiving peri-operative minocycline, will be compared with historical controls with regards to development of small strokes and persistent of these strokes on subsequent MRI imaging.

Conditions

Interventions

DRUG

Administration of minocycline

Administration of minocycline with the following schedule: * Day prior to procedure: 800mg p.o., 700mg p.o. * Day of procedure: 600mg i.v., 500mg p.o. * Day after procedure: 400mg p.o., 400mg p.o.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Georgios A Zenonos, MD · University of Pittsburgh Resident in Neurosurgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02178813 on ClinicalTrials.gov