Clinical trial NCT03413618: Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Official title: The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Postthrombotic Syndrome
Keywords: deep vein thrombosis
postthrombotic syndrome
anticoagulation
treatment
prevention
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open-labeled clinical trial with a masked outcomes assessor
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Recurrent Symptomatic or Asymptomatic DVT
timeFrame: 12 months
measure: Number of Participants With Symptomatic Pulmonary Embolism
timeFrame: 12 months
measure: The Value of Venous Clinical Severity Score
timeFrame: 12 months
measure: The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items
timeFrame: 12 months
measure: Number of Participants With Full Recanalization of the Popliteal Vein
timeFrame: 12 months
measure: Extension of Residual Venous Obstruction by Marder Score
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
measure: Major Bleeding
timeFrame: 12 months
measure: Clinically Relevant Non-major Bleeding
timeFrame: 12 months
measure: Minor Bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinical Hospital no.1 of the President's Administration of Russian Federation
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Ilya Schastlivtsev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lobastov K, Sautina E, Alencheva E, Bargandzhiya A, Schastlivtsev I, Barinov V, Laberko L, Rodoman G, Boyarintsev V. Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial. Ann Surg. 2021 Jul 1;274(1):63-69. doi: 10.1097/SLA.0000000000004556.