COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation

Recruiting now · Phase 4

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04642430

Run by

Ottawa Hospital Research Institute

People needed

3018

Starts

2021-07-06

Expected to finish

2027-12-31

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Confirmed new diagnosis of AF on ECG with an indication to start anticoagulation according to Canadian Cardiovascular Society guidelines

You may not qualify if…

• Creatinine clearance =<15 ml/min calculated using the Cockcroft-Gault formula
• Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to:
• active bleeding
• history of mechanical valve
• other indication for anticoagulation (e.g. mechanical valves, venous thrombosis)
• dual antiplatelet agent use
• known liver disease with coagulopathy
• use of contraindicated medications (strong inducers/inhibitors of CYP 3A4/5, P-glycoprotein)
• pregnancy or breastfeeding

Where it is running

• Ciusss Nim — Montreal, Quebec, Canada (enrolling)
• QEII Health Science Centre — Halifax, Nova Scotia, Canada (enrolling)
• Kingston General Hospital — Kingston, Ontario, Canada (enrolling)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (enrolling)
• University Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
• CISSS de l'Outaouais — Gatineau, Quebec, Canada (enrolling)
• Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada (enrolling)
• CHU de Quebec - Université Laval — Laval, Quebec, Canada

Full record on ClinicalTrials.gov

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