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

NCT03413618 | Completed Phase 4 Results

• 1 other identifier: RIDILOTT-DVT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis; Postthrombotic Syndrome

Keywords

deep vein thrombosis; postthrombotic syndrome; anticoagulation; treatment; prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (10)

• Number of Participants With Recurrent Symptomatic or Asymptomatic DVT

  12 months

• Number of Participants With Symptomatic Pulmonary Embolism

  12 months

• The Value of Venous Clinical Severity Score

  12 months

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

  12 months

• Number of Participants With Full Recanalization of the Popliteal Vein

  12 months

Study Arms (2)

Experimental: Rivaroxaban + Diosmin + Stockings

EXPERIMENTAL

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

Drug: Rivaroxaban; Drug: Diosmin; Other: compression stockings

Control: Rivaroxaban + Stockings only

ACTIVE COMPARATOR

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

Drug: Rivaroxaban; Other: compression stockings

Interventions

Rivaroxaban DRUG

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

Also known as: xarelto

Control: Rivaroxaban + Stockings only; Experimental: Rivaroxaban + Diosmin + Stockings

Diosmin DRUG

600 mg q.d. for 12 month

Also known as: flebodia

Experimental: Rivaroxaban + Diosmin + Stockings

compression stockings OTHER

above knee stocking for 12 month

Control: Rivaroxaban + Stockings only; Experimental: Rivaroxaban + Diosmin + Stockings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• The first episode of femoro-popliteal deep vein thrombosis (DVT)
• Verification of DVT by duplex ultrasound
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

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

Moscow, 121352, Russia

Location

Related Publications (1)

• 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.

  PMID: 33201130 RESULT

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Interventions

Rivaroxaban; Diosmin; Stockings, Compression

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Compression Bandages; Bandages; Equipment and Supplies

Limitations and Caveats

Unsuspected high frequency of PTS in the Control group (standard treatment with rivaroxaban and compression stockings) led to early termination of enrollment (75% of planned sample size).

Results Point of Contact

• Title: Dr. Kirill Lobastov
• Organization: Pirogov Russian National Research Medical University

lobastov_kv@hotmail.com

+7-985-211-63-31

Study Officials

• Ilya Schastlivtsev, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized open-labeled clinical trial with a masked outcomes assessor

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 29, 2018
• Study Start: December 20, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 4, 2021
• Results First Posted: January 27, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)