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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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

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Deep Vein Thrombosis Postthrombotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized open-labeled clinical trial with a masked outcomes assessor

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups

Study Groups

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Experimental: Rivaroxaban + Diosmin + Stockings

treatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

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

Diosmin

Intervention Type DRUG

600 mg q.d. for 12 month

compression stockings

Intervention Type OTHER

above knee stocking for 12 month

Control: Rivaroxaban + Stockings only

standard treatment of deep vein thrombosis with anticoagulation (rivaroxaban) and elastic compression stockings

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

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

compression stockings

Intervention Type OTHER

above knee stocking for 12 month

Interventions

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Rivaroxaban

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

Intervention Type DRUG

Diosmin

600 mg q.d. for 12 month

Intervention Type DRUG

compression stockings

above knee stocking for 12 month

Intervention Type OTHER

Other Intervention Names

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xarelto flebodia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No