Table 3.
An overview of major ongoing trials of aspirin (status: April 2011).
| Title | Identifier | Patients | Interventions | Aspirin dose |
Design / phase |
Start date | End date | Primary outcome | Follow- up |
|---|---|---|---|---|---|---|---|---|---|
| Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients |
NCT00578721 | Resected CRC |
Aspirin / arginine restriction |
325 mg/day |
Phase II |
September 2008 |
December 2012 |
Change in markers (putrescine) of polyamine reduction |
3 years |
| Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia |
NCT00468910 | History of CRC / adenomas |
Aspirin | 325 mg/day |
Phase II, RCT |
March 2007 |
April 2014 |
Change in spectral slope and fractal dimension in rectal biopsies |
3 months |
| Randomized Phase II Trial of Aspirin and Difluoromethylornithine (DFMO) in Patients at High Risk of Colorectal Cancer |
NCT00983580 | History of CRC / adenomas |
Aspirin and difluoromethyl oorithine |
325 mg/day |
Phase II, RCT |
August 2009 |
June 2015 |
Adenoma recurrence rate |
1 year |
| The Systematic Evaluation of Aspirin and Fish Oil polyp prevention (SeAFOod) |
SRCTN05926847 | High-risk colorectal adenoma patients |
Aspirin and eicosapen- taenoic acid- free fatty acid |
300 mg/day |
Phase III, RCT |
September 2011 |
October 2014 |
Number of colorectal adenomas |
1–3 years |
| Japan Colorectal Aspirin Polyps Prevention (J-CAPP) |
UMIN000000697 | Resected CRC |
Aspirin | 100 mg/day |
Phase III, RCT |
January 2007 |
December 2012 |
Newly developed tumors |
2–3 years |
| Aspirin for Dukes C and High Risk Dukes B Colon Cancer – An International, Multi- Centre, Double-blind, Randomised, Placebo- controlled, Phase III trial (ASCOLT) |
NCT00565708 | Dukes B, C colon or rectal cancer |
Aspirin | 200 mg/day |
Phase III, RCT |
December 2008 |
December 2019 |
Disease-free survival |
5 years |
| Aspirin in Reducing Events in the Elderly (ASPREE) |
NCT01038583 | Aged ≥70 years |
Aspirin 100 mg daily |
100 mg/day |
Phase III, RCT |
January 2010 |
August 2016 |
Any cause mortality , dementia, or persistent physical disability |
Every 3–6 months |
| Aspirin to Reduce Risk of Initial Vascular Events (ARRIVE) |
NCT00501059 | Males aged ≥ 55 years with 2 cardiac risk factors and females ≥ 60 years with 3 cardiac risk factors |
Aspirin 100 mg daily |
100 mg/day |
Phase III, RCT |
July 2007 |
January 2014 |
Any composite outcome of MI, stroke or CV death |
~ 5 years |
| Cancer Prevention Programme project 3 (CAPP3) |
In development | Carriers of a germline mismatch repair gene defect, age 18–60 years |
Aspirin | 100 mg, 300 mg or 600 mg daily for 5 years |
Phase II/III RCT |
2012 | 2020 | Lynch syndrome cancer |
At least 10 years |
CRC, colorectal cancer; RCT, randomized controlled trial; CV, cardiovascular.