Comparing bleeding risks of two blood thinners in patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the safety of two direct oral anticoagulants, apixaban and rivaroxaban, in patients diagnosed with non-valvular atrial fibrillation (AF). Participants will be monitored for clinically relevant bleeding events over the first 12 months of treatment. The study addresses a critical gap in existing research by providing direct head-to-head comparisons of these two medications, which are both approved for stroke prevention in AF. The findings will help inform clinical practice and guide the choice of anticoagulant therapy for patients.

Why it matters

Who can join: the full rules

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

Where it's running

• QEII Health Science Centre
  Halifax, Nova Scotia, Canada Recruiting
• Kingston General Hospital
  Kingston, Ontario, Canada Recruiting
• The Ottawa Hospital - General Campus
  Ottawa, Ontario, Canada Recruiting
• University Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting
• CISSS de l'Outaouais
  Gatineau, Quebec, Canada Recruiting
• Ciusss Nim
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Lana Castellucci, MD, FRCPC — Ottawa Hospital Research Institute
• Study coordinator: Lana Castellucci, MD
• Email: lcastellucci@toh.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.