Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Summary

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).

Timeline

Start

2012-04

Primary completion

2016-05

Completion

2016-05

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Rivaroxaban vs Fondaparinux; p = 0.0252; asymptotic test for non-inferiority NCT01499953 ↗

paper Rivaroxaban was non-inferior to fondaparinux for treatment of superficial-vein thrombosis PMID 28219692 ↗

Publications

• Kearon C, Carrier M, Gu CS, Schulman S, Bates SM, Kahn SR, Chagnon I, Nguyen DT, Wu C, Rudd-Scott L, Julian JA. Rivaroxaban Compared to Placebo for the Treatment of Leg Superficial Vein Thrombosis: A Randomized Trial. Semin Thromb Hemost. 2020 Nov;46(8):977-985. doi: 10.1055/s-0040-1718891. Epub 2020 Dec 23.
• Beyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, Sahin K, Bauersachs R; SURPRISE investigators. Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017 Mar;4(3):e105-e113. doi: 10.1016/S2352-3026(17)30014-5. Epub 2017 Feb 16.
• Werth S, Bauersachs R, Gerlach H, Rabe E, Schellong S, Beyer-Westendorf J. Superficial vein thrombosis treated for 45 days with rivaroxaban versus fondaparinux: rationale and design of the SURPRISE trial. J Thromb Thrombolysis. 2016 Aug;42(2):197-204. doi: 10.1007/s11239-016-1354-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fondaparinux	Other / unclassified	2.5 mg	Subcutaneous
Subject	Rivaroxaban	Other / unclassified	10 mg	—

Indications