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

Primary Purpose

Deep Vein Thrombosis, Postthrombotic Syndrome

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Rivaroxaban
Diosmin
compression stockings
Sponsored by
Pirogov Russian National Research Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, postthrombotic syndrome, anticoagulation, treatment, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Rivaroxaban + Diosmin + Stockings

Control: Rivaroxaban + Stockings only

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Number of Participants With Symptomatic Pulmonary Embolism
detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram
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)
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.
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%.
Extension of Residual Venous Obstruction by Marder Score
Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).
Adverse Events
any adverse events detected or suspected
Major Bleeding
according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells
Clinically Relevant Non-major Bleeding
any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment
Minor Bleeding
any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle

Full Information

First Posted
January 18, 2018
Last Updated
January 14, 2021
Sponsor
Pirogov Russian National Research Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03413618
Brief Title
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Acronym
RIDILOTT-DVT
Official Title
The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Postthrombotic Syndrome
Keywords
deep vein thrombosis, postthrombotic syndrome, anticoagulation, treatment, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized open-labeled clinical trial with a masked outcomes assessor
Masking
Outcomes Assessor
Masking Description
Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Rivaroxaban + Diosmin + Stockings
Arm Type
Experimental
Arm Description
treatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin
Arm Title
Control: Rivaroxaban + Stockings only
Arm Type
Active Comparator
Arm Description
standard treatment of deep vein thrombosis with anticoagulation (rivaroxaban) and elastic compression stockings
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
xarelto
Intervention Description
15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month
Intervention Type
Drug
Intervention Name(s)
Diosmin
Other Intervention Name(s)
flebodia
Intervention Description
600 mg q.d. for 12 month
Intervention Type
Other
Intervention Name(s)
compression stockings
Intervention Description
above knee stocking for 12 month
Primary Outcome Measure Information:
Title
Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score
Description
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 Outcome Measure Information:
Title
Number of Participants With Recurrent Symptomatic or Asymptomatic DVT
Description
detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound
Time Frame
12 months
Title
Number of Participants With Symptomatic Pulmonary Embolism
Description
detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram
Time Frame
12 months
Title
The Value of Venous Clinical Severity Score
Description
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
Title
The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items
Description
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
Title
Number of Participants With Full Recanalization of the Popliteal Vein
Description
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%.
Time Frame
12 months
Title
Extension of Residual Venous Obstruction by Marder Score
Description
Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).
Time Frame
12 months
Title
Adverse Events
Description
any adverse events detected or suspected
Time Frame
12 months
Title
Major Bleeding
Description
according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells
Time Frame
12 months
Title
Clinically Relevant Non-major Bleeding
Description
any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment
Time Frame
12 months
Title
Minor Bleeding
Description
any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Schastlivtsev, PhD
Organizational Affiliation
Pirogov Russian National Research Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital no.1 of the President's Administration of Russian Federation
City
Moscow
ZIP/Postal Code
121352
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33201130
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.
Results Reference
result

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

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