Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
Venous ThromboembolismApixaban 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* 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 Criteria:
* 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)
Study Location
St. Paul's Hospital
St. Paul's HospitalVancouver, British Columbia
Canada
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Tony Wan, MD
St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare HamiltonHamilton, Ontario
Canada
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James Douketis, MD
UHN - Toronto General Hospital
UHN - Toronto General HospitalToronto, Ontario
Canada
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Erik Yeo, MD
McGill University Health Center
McGill University Health CenterMontréal, Quebec
Canada
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Marc Rodger, MD
Alberta Health Sciences
Alberta Health SciencesEdmonton, Alberta
Canada
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Juravinski Hospital
Juravinski HospitalHamilton, Ontario
Canada
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Peter Gross, MD
Sam Schulman, MD
The Ottawa Hospital - General Campus
The Ottawa Hospital - General CampusOttawa, Ontario
Canada
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Jewish General Hospital
Jewish General HospitalMontréal, Quebec
Canada
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Susan Kahn, MD, FRCPC
QEII Health Science Centre
QEII Health Science CentreHalifax, Nova Scotia
Canada
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Kingston General Hospital
Kingston General HospitalKingston, Ontario
Canada
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Kerstin de Wit, MD
Hôpital Sacré-Coeur de Montréal
Hôpital Sacré-Coeur de MontréalMontreal, Quebec
Canada
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Isabelle Chagnon, MD
CHU de Québec-Université Laval
CHU de Québec-Université LavalQuebec city, Quebec
Canada
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Benoit Cote, MD
University of Calgary
University of CalgaryCalgary, Alberta
Canada
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Deepa Suryanarayan, MD
Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
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Davide Matino, MD
Sam Schulman, MD
London Health Sciences Center
London Health Sciences CenterLondon, Ontario
Canada
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Michael Kovacs, MD
St. Mary's Hospital
St. Mary's HospitalMontreal, Quebec
Canada
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University of Sherbrooke
University of SherbrookeSherbrooke, Quebec
Canada
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- Study Sponsored By
- Ottawa Hospital Research Institute
- Participants Required
- More Information
- Study ID:
NCT03266783