Prevention of post-operative complications by using HMG-CoA Reductase Inhibitor in patients undergoing oesophagectomy - A multicentre, randomised, double blind, placebo controlled trial - Simvastatin to prevent complications after oesophagectomy v1.0

Belfast Health and Social Care Trust0 个研究点目标入组 452 人开始时间: 2016年3月29日最近更新: 2016年10月3日

试验速览

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•1.Adult patients =18 years of age undergoing elective oesophagectomy
•2.Female subjects must be surgically sterile, or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 30 days after completion of treatment. A pregnancy test, measured by urine HCG in females with child bearing potential, will be performed at pre-operative assessment clinic
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 252
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1.Age < 18 years
•2.Creatinine Kinase (CK) > 5 times upper limit normal range in the local laboratory
•3.Known active liver disease (Child’s Pugh score > 11) or abnormal liver function tests i.e. transaminases (AST or ALT) > 3 times upper limit normal range in the local laboratory
•4.Renal impairment (calculated creatinine clearance less than 30mL/minute)
•5.Inability to take oral medication pre-operatively
•6.Subject reported lactose intolerance
•7.Participation in other intervention trials within 30 days.
•8.Current treatment with statins
•9.Known hypersensitivity to the study medication
•10.Previous adverse reaction to statins
•11.Concomitant use of fibrates or other lipid-lowering therapy
•12.Concomitant use of itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprivir, telaprevir, nefazodone, cyclosporine, danazol, amiodarone, amlodipine, verapamil or diltiazem, fusidic acid
•13.Patients must be able to understand and give signed and dated informed consent indicating that they understand all the pertinent aspects of the trial prior to enrolment

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