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Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

Venous Thromboembolism

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.

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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 Hospital
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Tony Wan, MD

St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

James Douketis, MD

UHN - Toronto General Hospital
UHN - Toronto General Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Erik Yeo, MD

McGill University Health Center
McGill University Health Center
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Marc Rodger, MD

Alberta Health Sciences
Alberta Health Sciences
Edmonton, Alberta
Canada

Contact Study Team

Juravinski Hospital
Juravinski Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Peter Gross, MD

Backup Contact

Sam Schulman, MD

The Ottawa Hospital - General Campus
The Ottawa Hospital - General Campus
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Lana Castellucci, MD, FRCPC

[email protected]
613-737-8899
Backup Contact

Erin Thomas

[email protected]
613-737-8899
Jewish General Hospital
Jewish General Hospital
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Susan Kahn, MD, FRCPC

QEII Health Science Centre
QEII Health Science Centre
Halifax, Nova Scotia
Canada

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Kingston General Hospital
Kingston General Hospital
Kingston, Ontario
Canada

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Primary Contact

Kerstin de Wit, MD

Hôpital Sacré-Coeur de Montréal
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec
Canada

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Primary Contact

Isabelle Chagnon, MD

CHU de Québec-Université Laval
CHU de Québec-Université Laval
Quebec city, Quebec
Canada

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Primary Contact

Benoit Cote, MD

University of Calgary
University of Calgary
Calgary, Alberta
Canada

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Primary Contact

Deepa Suryanarayan, MD

Hamilton General Hospital
Hamilton General Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Davide Matino, MD

Backup Contact

Sam Schulman, MD

London Health Sciences Center
London Health Sciences Center
London, Ontario
Canada

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Primary Contact

Michael Kovacs, MD

St. Mary's Hospital
St. Mary's Hospital
Montreal, Quebec
Canada

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University of Sherbrooke
University of Sherbrooke
Sherbrooke, Quebec
Canada

Contact Study Team

Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT03266783