NCT03413618

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

The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Deep vein thrombosis is an acute inflammatory disease that affects vein wall and leads to the structural changes in the wall and valves reflected with chronic venous insufficiency that called postthrombotic syndrome (PTS). Diosmin as a flavonoid agent has properties to reduce leukocyte-endothelial interaction and inflammatory response, that could reduce the damage to venous wall and valves. The hypothesis of the study is based on assumption that diosmin combined with standard anticoagulation can improve outcomes of femoro-popliteal DVT due to increase speed of veins recanalization, decrease of vein wall inflammation and finally decrease the incidence of PTS at 6 month and 1 year after index DVT.

Conditions

• Deep Vein Thrombosis
• Postthrombotic Syndrome

Interventions

Type	Name	Description
DRUG	Rivaroxaban	15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month
DRUG	Diosmin	600 mg q.d. for 12 month
OTHER	compression stockings	above knee stocking for 12 month

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-01-29
• Last updated: 2021-02-04
• Results posted: 2020-01-27

Locations

1 site across 1 country: Russia