Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

Summary

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

Timeline

Start

2014-03-05

Primary completion

2016-09-22

Completion

2016-11-04

Outcome

Mixed primary results

registry analysis (superiority or other test); Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD vs Acetylsalicylic (ASA) 100 mg, OD; p = 0.0001; Hazard Ratio (HR) 0.34 NCT02064439 ↗

registry analysis (superiority or other test); Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD vs Acetylsalicylic (ASA) 100 mg, OD; p <0.0001; Hazard Ratio (HR) 0.26 NCT02064439 ↗

registry analysis (superiority or other test); Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD vs Acetylsalicylic (ASA) 100 mg, OD; p = 0.3235; Hazard Ratio (HR) 2.01 NCT02064439 ↗

Publications

• Background Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.
• Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.
• Yamada N, Fu W, Shi Z, Park KH, Kim HS, Dai X, Lensing AW, Pap AF, Kohno T, Tajima T, Watakabe T, Mitsumori T. Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE. Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4.
• Flumignan CD, Nakano LC, Baptista-Silva JC, Flumignan RL. Antiplatelet agents for the treatment of deep venous thrombosis. Cochrane Database Syst Rev. 2022 Jul 25;7(7):CD012369. doi: 10.1002/14651858.CD012369.pub2.
• Weitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Freitas MCS, Holberg G, Kakkar AK, Haskell L, van Bellen B, Pap AF, Berkowitz SD, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017 Mar 30;376(13):1211-1222. doi: 10.1056/NEJMoa1700518. Epub 2017 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetylsalicylic Acid	Unknown	100 mg	—
Subject	Rivaroxaban	Other / unclassified	10 mg	—
Subject	Rivaroxaban	Other / unclassified	20 mg	—

Indications