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Rivaroxaban With Diosmine in Long-term Treatment of DVT (RIDILOTT-DVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03413618
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pirogov Russian National Research Medical University

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Postthrombotic Syndrome Drug: Rivaroxaban Drug: Diosmin Other: compression stockings Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open-labeled clinical trial with a masked outcomes assessor
Masking: Single (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
Primary Purpose: Treatment
Official Title: The Efficacy of Rivaroxaban With Diosmine in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Study group
treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin
Drug: Rivaroxaban
15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month
Other Name: xarelto

Drug: Diosmin
600 mg q.d. for 12 month
Other Name: flebodia

Other: compression stockings
above knee stocking for 12 month

Active Comparator: Control group
standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings
Drug: Rivaroxaban
15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month
Other Name: xarelto

Other: compression stockings
above knee stocking for 12 month




Primary Outcome Measures :
  1. postthrombotic syndrome [ Time Frame: 12 month ]
    detection of postthrombotic syndrome according to the Villalta score (5+ scores)


Secondary Outcome Measures :
  1. recurrent symptomatic or asymptomatic deep vein thrombosis [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month ]
    detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound

  2. symptomatic pulmonary embolism [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month ]
    detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram

  3. severity of chronic venous disease [ Time Frame: 6 and 12 month ]
    the severity of chronic venous disease assessed with VCSS score

  4. quality of life [ Time Frame: 6 and 12 month ]
    the quality of life assessed with CIVIQ-20 questionnaire

  5. degree of the residual venous obstruction [ Time Frame: 2, 4, 6, 8, 10, 12 month ]
    the degree of the residual venous obstruction assessed by the compressibility of the main venous segments (femoral vein, superficial femoral vein, popliteal femoral vein) by duplex ultrasound

  6. extension of residual venous obstruction [ Time Frame: 2, 4, 6, 8, 10, 12 month ]
    the extension of residual venous obstruction (thrombotic masses occupying 20% and more of the vein cross-sectional diameter) assessed by the modified Marder score

  7. adverse events [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month ]
    any adverse events detected or suspected

  8. major bleeding [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month ]
    according to ISTH definition

  9. clinically relevant non-major bleeding [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month ]
    any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment

  10. minor bleeding [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month ]
    any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suspicion of 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 (APL, deficiency of proteins C, S, AT-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 ASA in a dose of not more than 100 mg).
  • Low compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413618


Locations
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Russian Federation
Clinical Hospital no.1 of the President's Administration of Russian Federation
Moscow, Russian Federation, 121352
Sponsors and Collaborators
Pirogov Russian National Research Medical University
Investigators
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Principal Investigator: Ilya Schastlivtsev, PhD Pirogov Russian National Research Medical University

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Responsible Party: Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier: NCT03413618     History of Changes
Other Study ID Numbers: RIDILOTT-DVT
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Pirogov Russian National Research Medical University:
deep vein thrombosis
postthrombotic syndrome
anticoagulation
treatment
prevention

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants