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

• Status: Completed
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pirogov Russian National Research Medical University
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Age over 18 years

• The first episode of femoro-popliteal deep vein thrombosis (DVT)

• Verification of DVT by duplex ultrasound

• Informed consent signed

Exclusion Criteria:

• Suspicion of pulmonary embolism (PE)

• Verified PE

• Bilateral DVT

• Contraindications for rivaroxaban (in accordance with the official instructions)

• Contraindications for diosmin (in accordance with the official instructions)

• Active cancer

• Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C, S, antithrombin 3)

• Use of other anticoagulants for more than 7 days from the DVT verification

• Impossibility of using compression stocking after 3 days from DVT verification

• Performed surgical intervention on the superficial or deep veins of the lower extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior cava filter)

• Continuous use of other drugs that affect the hemostasis system (except for acetylsalicylic acid in a dose of not more than 100 mg).

• Low compliance