RecruitingPhase 4NCT04642430

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


Sponsor

Ottawa Hospital Research Institute

Enrollment

3,018 participants

Start Date

Jul 6, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two common blood-thinning medications — rivaroxaban and apixaban — to see which has a lower risk of bleeding in patients with atrial fibrillation (irregular heartbeat). **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with atrial fibrillation confirmed on an ECG - Your doctor has determined you need a blood thinner **You may NOT be eligible if...** - You have very poor kidney function (creatinine clearance 15 or below) - You have active bleeding - You have a mechanical heart valve - You need blood thinners for a different reason (such as a blood clot) - You are on two antiplatelet medications (like aspirin plus clopidogrel) - You have liver disease that affects blood clotting - You are taking medications that interact with these blood thinners - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApixaban

Refer to Apixaban group

DRUGRivaroxaban

Refer to Rivaroxaban group


Locations(8)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

QEII Health Science Centre

Halifax, Nova Scotia, Canada

Kingston General Hospital

Kingston, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

University Ottawa Heart Institute

Ottawa, Ontario, Canada

CISSS de l'Outaouais

Gatineau, Quebec, Canada

CHU de Quebec - Université Laval

Laval, Quebec, Canada

Ciusss Nim

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT04642430


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