At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
In Brief
A Phase 4 clinical trial evaluating Apixaban and Rivaroxaban for Venous Thromboembolism. Completed, enrolled 2,760 participants across 19 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Arms & Interventions
10 mg orally (PO), twice a day (BID) for 1 week, then 5 mg PO BID for 3 months of treatment
15 mg orally (PO), twice a day (BID) for 3 weeks, then 20 mg PO once a day (OD) for 3 months of treatment
Interventions
Refer to Apixaban group
Refer to Rivaroxaban group