COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
Atrial Fibrillation (AF) affects 200,000 Canadians and increases risk of stroke, morbidity
and mortality. Having a stroke can affect a patient's ability to speak, eat, walk, work, care
for themselves, and interact with others. Not only can it ruin one's life, but it can also be
fatal. A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain
cells of oxygen. In people with atrial fibrillation, blood flow is sluggish in the top
chambers of the heart, and blood clots can form there. When a piece of a clot breaks off, it
can travel to the brain and cause a stroke. That's where blood thinners come in. Blood
thinners, or anticoagulants, decrease the chances of blood clots forming in the heart,
reducing the risk of stroke. Studies show that blood thinners are highly effective at
reducing the risk of stroke by up to 95%.
The conventional blood thinner is warfarin, taken by mouth. Warfarin requires regular blood
tests to make sure a patient getting the correct dose. The patient also may have to avoid
certain foods since the medication can interact with them. Newer blood thinners, known as
direct-oral anticoagulants (DOACs) are available, which do not require regular blood tests
and do not interact with foods. Two of the new blood thinners are called rivaroxaban and
apixaban. Like warfarin, they can be taken by mouth, and studies have shown them to be as
effective as warfarin.
Both rivaroxaban and apixaban have been approved for stroke prevention in AF by Health
Canada. However, there have been no direct head-to-head comparisons of these two
anticoagulants, meaning comparative safety data is not available. Increasing use of DOACs for
stroke prevention in AF and patient values around bleeding highlight the need for a
comparison trial to ensure patients receive the anticoagulant with the greatest balance of
benefit to potential harm.
The trial is to assess bleeding rates and superiority of using apixaban versus rivaroxaban in
patients with non-valvular atrial fibrillation.
Phase:
Phase 4
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborators:
Canadian Institutes of Health Research (CIHR) Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network