Stroke Clinical Trial
Official title:
The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization. A Phase I Study
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.
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