Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
Key facts
- Who runs it
- Ottawa Hospital Research Institute
- Where
- Australia, Canada, and Ireland19 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 2,760 people enrolled
- Started
- 13 Dec 2017
- Ended
- 15 Oct 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Apixaban
- Rivaroxaban
- Record updated
- 24 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Confirmed newly diagnosed symptomatic acute venous thromboembolism (VTE) [proximal lower extremity deep vein thrombosis (DVT) or segmental or greater pulmonary embolism (PE)]
- Age ≥ 18 years old
- Informed consent obtained
Who cannot take part
- Have received > 72 hours of therapeutic anticoagulation
- Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to:; active bleeding,; active malignancy, defined as a) diagnosed with cancer within the past 6 months; or b) recurrent, regionally advanced or metastatic disease; or c) currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or d) a hematologic malignancy not in complete remission,; weight > 120 kg,; liver disease (Child-Pugh Class B or C),; use of contraindicated medications; another indication for long-term anticoagulation (e.g. atrial fibrillation); pregnant (note below) or breastfeeding (Note: as reported by the patient or a pregnancy test will be ordered at the discretion of the treating physician for women of childbearing potential as per standard of care)
- Creatinine clearance < 30 ml/min calculated with the Cockcroft-Gault formula
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE.
The 2 groups in the trial
- Apixaban groupExisting treatment, for comparison
10 mg orally (PO), twice a day (BID) for 1 week, then 5 mg PO BID for 3 months of treatment
Treatment: Apixaban
- Rivaroxaban groupExisting treatment, for comparison
15 mg orally (PO), twice a day (BID) for 3 weeks, then 20 mg PO once a day (OD) for 3 months of treatment
Treatment: Rivaroxaban
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Publications
- Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism.The New England journal of medicine, 2026
- Record updated
- 24 June 2026