Recruiting

Rivaroxaban vs. Apixaban

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04642430

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apixaban

Rivaroxaban

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT04642430

Start date

Jul 6, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3018 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Apixaban group

5 mg PO, twice daily for 12 months of treatment. A dose reduction\* to 2.5 mg twice daily will apply if patients meet 2 of 3 following criteria: age > 80 years; weight < 60 kg; creatinine >133 micromol/L.

\*Patients with AF who are receiving DOAC should have their renal function assessed at baseline and at least annually

active comparator: Rivaroxaban Group

20 mg PO, once daily for 12 months of treatment. A dose reduction\* to 15 mg daily will apply to patients with creatinine clearance <50 ml/min.

\*Patients with AF who are receiving DOAC should have their renal function assessed at baseline and at least annually

Interventions

Apixaban

Refer to Apixaban group

Rivaroxaban

Refer to Rivaroxaban group

Primary outcome measure

  • The rate of adjudicated clinically relevant bleeding (CRB) events [ Time Frame: For the duration of the study: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Victoria Cardiac Arrhythmia Trials

Recruiting

Victoria, British Columbia, Canada, V8Z 0B9

Contacts

Principal Investigator:

Dr. Laurence Sterns, MD

QEII Health Science Centre

Recruiting

Halifax, Nova Scotia, Canada

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Lana Castellucci, MD, FRCPC

lcastellucci@toh.ca

University Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada

CISSS de l'Outaouais

Recruiting

Gatineau, Quebec, Canada, J8T 4J3

Contacts

Principal Investigator:

Dr. Jean-Michel Guay, MD

Ciusss Nim

Recruiting

Montreal, Quebec, Canada, H3L 1K5

Contacts

Principal Investigator:

Dr. Alexis Cournoyer, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Stroke Prevention
  • Bleed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-04-22.