Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

Phase 4 Completed 90 enrolled Pirogov Russian National Research Medical University

RandomizedParallel-groupSingle-blindTreatment

Summary

The randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.

Timeline

Start: 2017-12-20
Primary completion: 2019-07-31
Completion: 2019-07-31

Outcome

Met primary endpoint

registry analysis (superiority test); Experimental: Rivaroxaban + Diosmin + Stockings vs Control: Rivaroxaban + Stockings Only; p <0.0001; Fisher Exact NCT03413618 ↗

Publications

Results Lobastov K, Sautina E, Alencheva E, Bargandzhiya A, Schastlivtsev I, Barinov V, Laberko L, Rodoman G, Boyarintsev V. Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial. Ann Surg. 2021 Jul 1;274(1):63-69. doi: 10.1097/SLA.0000000000004556.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diosmin	Small molecule	600 mg	—
Background	Rivaroxaban	Other / unclassified	20 mg	—