The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization
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|ClinicalTrials.gov Identifier: NCT02178813|
Recruitment Status : Terminated (Study stopped prematurely because of multiple logistic difficulties)
First Posted : July 1, 2014
Last Update Posted : June 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Administration of minocycline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization. A Phase I Study|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Administration of minocycline
All patients in the study will receive minocycline periprocedurally with the following schedule:
Drug: Administration of minocycline
Administration of minocycline with the following schedule:
Other Name: Minocycline (generic name)
- Drug Safety/Tolerability (Number of patients that require discontinuation of drug because of side effects) [ Time Frame: One day prior to procedure to 1 days after procedure ]
The primary aim of this phase I study is to establish the safety and tolerability of this drug in patient population undergoing carotid revascularization procedures by monitoring complete blood counts, liver enzymes, renal function tests, and clinical side effects
During the above time frame (one day prior to procedure until 1 day after the procedure) the number of patients that develop any side effects requiring discontinuation of the drug will be noted.
Side effects that will lead to discontinuation of the drug are the following:
- The patient reports a clinical side effect as intolerable (nausea /vomiting, dysphagia, rash, vertigo or other side effects attributable to the administration of minocycline)
- Change in liver function tests ( 2 times elevation of alanine-aminotransferase above the normal range)
- Change in renal function tests (creatinine more than 1.5 points from baseline)
- Progression of procedural stroke on MRI imaging [ Time Frame: 10 days before procedure, 1 day after procedure, 1 month after procedure ]Secondary Aim 1:To examine the effect of perioperative treatment with minocycline on the number and overall volume of new neurologic ischemic lesions detected by Diffusion Weighted Imaging (DWI) within 24 hours following carotid revascularization, and on the conversion of these acute lesions to persistent changes on Magnetic Resonance Imaging (MRI) fluid-attenuated inversion recovery (FLAIR) sequences. The findings in the study's cohort of patients will be compared to historical controls
- Neuropsychological test performance [ Time Frame: 10 days prior to procedure, 1 day after procedure, 1 month after procedure ]To examine the effect of perioperative minocycline on neuropsychological test performance. The findings in the study's cohort of patients will be compared to historical controls
- Myocardial Infarction [ Time Frame: Days 1, 2(procedure day), 3 ]To examine the effect of preoperative minocycline on the incidence of myocardial infarction during carotid revascularization procedures. The findings in the study's cohort of patients will be compared to historical controls. Myocardial infarction will be investigated based on clinical grounds, electrocardiographic findings, and elevation of troponins.
- Markers of neuronal injury [ Time Frame: 1 day prior to procedure, 1 day after the procedure, 1 month after the procedure ]To examine the effect of perioperative minocycline on markers of neuronal injury (Neuron Specific Enolase and S100b) as well as inflammation C- reactive protein). The findings in the study's cohort of patients will be compared to historical controls
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178813
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15206|
|Principal Investigator:||Georgios A Zenonos, MD||University of Pittsburgh Resident in Neurosurgery|