The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization
Status:
Terminated
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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.