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 sites452 target enrollmentMarch 29, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 29, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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