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CompletedPhase 4

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
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
Record updated
24 June 2026