Status:
COMPLETED
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Canadian Institutes of Health Research (CIHR)
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
VTE is the third leading cause of mortality by cardiovascular disease. Standard treatment for acute VTE uses a combination of parenteral Low-Molecular-Weight Heparin (LMWH) and oral vitamin K antagoni...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Have received \> 72 hours of therapeutic anticoagulation
- Creatinine clearance \< 30 ml/min calculated with 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,
- 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)
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2025
Estimated Enrollment :
2760 Patients enrolled
Trial Details
Trial ID
NCT03266783
Start Date
December 13 2017
End Date
September 8 2025
Last Update
November 17 2025
Active Locations (19)
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1
The University of Sydney
Darlington, New South Wales, Australia, 200606
2
University of Calgary
Calgary, Alberta, Canada
3
Alberta Health Sciences
Edmonton, Alberta, Canada
4
St. Paul's Hospital
Vancouver, British Columbia, Canada