Prevention of heart and lung complications by using simvastatin in patients undergoing surgery for removal of food pipe

Phase 1

• Conditions: Post-operative complications - Post-operative Pulmonary complication, Acute Respiratory Distress Syndrome and Myocardial Infarction; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-004424-65-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-29
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified