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

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.

Timeline

Start

2017-12-13

Primary completion

2025-04-30

Completion

2025-10-15

Publications

• Castellucci LA, Chen VM, Kovacs MJ, Lazo-Langner A, Greenstreet P, Kahn S, Cote B, Schulman S, de Wit K, Douketis J, Suryanarayan D, Wan T, Yeo E, Le Templier G, Tran HA, Willcox A, Crowther HJ, Prasad R, Shivakumar S, Umana E, Ni Ainle F, Tritschler T, Barco S, Galanaud JP, Blondon M, Baumann Kreuziger L, Solymoss S, Kearon C, Thomas E, Ramsay T, Le Gal G, Rodger M; COBRRA Trial Investigators. Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism. N Engl J Med. 2026 Mar 12;394(11):1051-1060. doi: 10.1056/NEJMoa2510703.

Drugs

Indications