Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis (RIDILOTT-DVT)

Pirogov Russian National Research Medical University

Status and phase

Completed

Phase 4

Conditions

Deep Vein Thrombosis

Postthrombotic Syndrome

Treatments

Drug: Rivaroxaban

Other: compression stockings

Drug: Diosmin

Study type

Interventional

Funder types

Other

Identifiers

NCT03413618

RIDILOTT-DVT

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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