NCT04642430 COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation
| NCT ID | NCT04642430 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,018 participants |
| Start Date | 2021-07-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,018 participants in total. It began in 2021-07-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Confirmed new diagnosis of AF on ECG with an indication to start anticoagulation according to Canadian Cardiovascular Society guidelines Exclusion Criteria: * 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
Contact & Investigator
Lana Castellucci, MD, FRCPC
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT04642430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04642430 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04642430 currently recruiting?
Yes, NCT04642430 is actively recruiting participants. Contact the research team at lcastellucci@toh.ca for enrollment information.
Where is the NCT04642430 trial being conducted?
This trial is being conducted at Victoria, Canada, Halifax, Canada, Kingston, Canada, Ottawa, Canada and 4 additional locations.
Who is sponsoring the NCT04642430 clinical trial?
NCT04642430 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Lana Castellucci, MD, FRCPC at Ottawa Hospital Research Institute. The trial plans to enroll 3,018 participants.
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