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

Terminated

Phase 1 Results N/A

Trial Description

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.

Trial Stopped: Study stopped prematurely because of multiple logistic difficulties

Conditions

Interventions

  • Administration of minocycline Drug
    Other Names: Minocycline (generic name)
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Administration of minocycline
    Description: All patients in the study will receive minocycline periprocedurally 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.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Drug Safety/Tolerability (Number of patients that require discontinuation of drug because of side effects) One day prior to procedure to 1 days after procedure Yes
Secondary Progression of procedural stroke on MRI imaging 10 days before procedure, 1 day after procedure, 1 month after procedure No
Secondary Neuropsychological test performance 10 days prior to procedure, 1 day after procedure, 1 month after procedure No
Secondary Myocardial Infarction Days 1, 2(procedure day), 3 No
Secondary Markers of neuronal injury 1 day prior to procedure, 1 day after the procedure, 1 month after the procedure No

Sponsors