Actively Recruiting
COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation
Led by Ottawa Hospital Research Institute · Updated on 2026-04-22
3018
Participants Needed
8
Research Sites
338 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
C
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed new diagnosis of atrial fibrillation on ECG with an indication to start anticoagulation according to Canadian Cardiovascular Society guidelines
You will not qualify if you...
- Creatinine clearance less than or equal to 15 ml/min calculated using Cockcroft-Gault formula
- Contraindications for anticoagulation with apixaban or rivaroxaban including active bleeding
- History of mechanical heart valve
- Other indications for anticoagulation such as mechanical valves or venous thrombosis
- Use of dual antiplatelet agents
- Known liver disease with coagulopathy
- Use of medications that strongly induce or inhibit CYP 3A4/5 or P-glycoprotein
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada, V8Z 0B9
Actively Recruiting
2
QEII Health Science Centre
Halifax, Nova Scotia, Canada
Actively Recruiting
3
Kingston General Hospital
Kingston, Ontario, Canada
Actively Recruiting
4
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
5
University Ottawa Heart Institute
Ottawa, Ontario, Canada
Actively Recruiting
6
CISSS de l'Outaouais
Gatineau, Quebec, Canada, J8T 4J3
Actively Recruiting
7
CHU de Quebec - Université Laval
Laval, Quebec, Canada
Not Yet Recruiting
8
Ciusss Nim
Montreal, Quebec, Canada, H3L 1K5
Actively Recruiting
Research Team
L
Lana Castellucci, MD, FRCPC
CONTACT
E
Erin Thomas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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