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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
• Treatments: Apixaban; Rivaroxaban

Criteria

Inclusion Criteria:

• Confirmed newly diagnosed symptomatic acute VTE (proximal power extremity DVT or segmental or greater 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)