A Phase 2 Randomised, Double-blind, Placebo-controlled Study of the Effects of VIA-2291, a 5-lipoxygenase Inhibitor, on Atherosclerotic Plaque and Biomarkers of Vascular Inflammation in Patients with Carotid Stenosis Undergoing Elective Carotid Endarterectomy. - VIA-2291-02

VIA PHARMACEUTICALS, INC.0 个研究点目标入组 80 人开始时间: 2007年1月18日最近更新: 2012年3月19日

研究概览

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•Willing and able to provide written informed consent Males or females 30-80 years of age Female patients must be either of non-childbearing potential i.e., surgically sterilised or post menopausal 8805;12 consecutive months without menses or, must have a negative pregnancy test at screening, not be breast feeding, and must be using an acceptable method of birth control which must continue to be used throughout the study and for 2 months after the end of the patient s participation in the study Carotid stenosis between 60 and 90 and to be scheduled for CEA surgery Clinically stable at the time of randomisation One or more of the following clinical features Prior history 4 weeks of cerebrovascular accident CVA or transient ischemic attack consistent with North American Symptomatic Carotid Endarterectomy Trial NASCET criteria or prior history of amaurosis fugax occurring at any time Diabetes haemoglobin Hb A1c between 7.0 and 11 or a history of two or more fasting blood glucose levels 125 mg/dL Baseline hsCRP 2 mg/L Echolucent plaque Grey Scale Median GSM 25 on carotid ultrasound
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Acute CVA within 4 weeks of enrollment Renal insufficiency defined as creatinine 1.5 x upper limit of normal ULN Any liver disease, cirrhosis, recent hepatitis, alanine aminotransferase ALT 1 x ULN i.e., above the normal range or positive screening test for hepatitis B hepatitis B surface antigen or hepatitis C by ELISA Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as HbA1c 11 at screening Congestive heart failure CHF defined by the New York Heart Association as functional Class III or IV Recent acute coronary syndrome event or coronary artery bypass graft CABG surgery within 4 weeks of enrollment Atrial fibrillation Planned cardiac intervention e.g., percutaneous coronary intervention or CABG within the next 3 months Any medical condition which in the investigator s opinion could detract from the interpretation of results such as but not limited to malignant, autoimmune, chronic infections, or chronic inflammatory conditions which could affect the biomarkers used in this study Participation in any other investigational drug study within 30 days of screening History of alcohol or drug abuse per Diagnostic and Statistical Manual-IV criteria see within the past year Acetaminophen use in any form in the 7 days before enrollment

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