ACETYLSALICYLIC ACID AS SECONDARY PREVENTION IN COLORECTAL CANCER (ASAC TRIAL) A multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial with ASA in patients undergoing liver resection for CRC metastasis - ASAC

Oslo University Hospital0 个研究点目标入组 800 人开始时间: 2017年12月19日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•All subjects undergoing liver resection for CRCLM as a part of a curative
•intent may be included in the study if
•They meet one of the following criteria:
•o First time CRCLM (synchronous or metachronous)
•o Recurrence of CRCLM (not previously included in this trial)
•Histologically verified free resection margins (R0 resection or R1 (<1mm margin + chemotherapy))
•Must be ambulatory with a performance status ECOG 0-2
•Must be at least 18 years of age
•Signed informed consent and expected cooperation of the patients for
•the treatment and follow up must be obtained and documented
•according to ICH GCP, and national/local regulations.
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or klopidogrel
•Ongoing regular use of corticosteroids, NSAIDs
•Inherited or acquired coagulopathy (hemophilia)
•Severe heart failure (classified as NYHA class >III) or kidney failure
•CRCLM treated with radiofrequency or microwave ablation technique
•Pregnancy or breastfeeding (negative pregnancy test will be required
•when indicated)
•Childbearing potential without proper contraceptive measures such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to avoid pregnancy for the entire study period
•Liver cirrhosis with a Child-Pugh score >B7
•Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl:
•Hypersensitivity/allergies to ASA
•Previous severe gastrointestinal haemorrage/peptic ulcer due to ASA/NSAID
•Active peptic ulcer
•Hemophilia
•Need to use medications contraindicated according to SmPC of
•Trombyl from Medicines Agency

发起方

Oslo University Hospital