Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients
Status:
Completed
Trial end date:
2018-10-19
Target enrollment:
Participant gender:
Summary
Cancer patients have an increased risk of developing blood clots in the veins compared to
non-cancer patients. Cancer patients who develop blood clots can lead to reduced life
expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most
effective way to decrease the complications associated with blood clots in the veins.
Although previous clinical trials have shown some benefit on the use of medication to prevent
blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive
in demonstrating that existing blood thinners significantly reduce the rate of blood clots in
cancer patients. One possible explanation relates to the fact that these studies have
included a large proportion of cancer patients who are a low risk of developing blood clots
in the veins. We are proposing to identify cancer patients who are at a high risk of
developing blood clots by using a validated tool at the time of their cancer diagnosis. The
identified high risk cancer patients will be asked to participate in a trial to test the
safety and efficacy of a new oral medication that has been used to prevent blood clots in
patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa,
Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will
receive the study drug and 287 will receive an inactive substance. Analysis will be performed
to assess the safety and the superiority of the study drug.
Phase:
Phase 2
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborators:
Bristol-Myers Squibb Canadian Institutes of Health Research (CIHR)