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

Pirogov Russian National Research Medical University90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Deep Vein Thrombosis Postthrombotic Syndrome

Interventions

RivaroxabanDRUG

15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month

DiosminDRUG

600 mg q.d. for 12 month

compression stockingsOTHER

above knee stocking for 12 month

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Hospital no.1 of the President's Administration of Russian Federation

Moscow, Russia

Outcomes

Primary Outcomes

Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score

Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores.

Time frame: 12 months

Secondary Outcomes

Number of Participants With Recurrent Symptomatic or Asymptomatic DVT

detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound

Time frame: 12 months

Number of Participants With Symptomatic Pulmonary Embolism

detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram

Time frame: 12 months

The Value of Venous Clinical Severity Score

Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD)

Time frame: 12 months

The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items

Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores.

Time frame: 12 months

Number of Participants With Full Recanalization of the Popliteal Vein

Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%.

Data from ClinicalTrials.gov

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