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Deep Vein ThrombosisPhase 4RIDILOTT-DVTNCT03413618

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

A Phase 4 study testing Rivaroxaban, Diosmin and compression stockings in people with Deep Vein Thrombosis and Postthrombotic Syndrome, run by Pirogov Russian National Research Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deep Vein Thrombosis, Postthrombotic Syndrome
What is being tested?
Rivaroxaban, Diosmin and compression stockings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteRussia
Study dates
20 Dec 2017to 31 Jul 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow, 121352

Other trials in Russia

About this study

Official title: The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis

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.

Read the 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.

Being tested
Rivaroxaban, Diosmin, compression stockings
Keywords
deep vein thrombosis, postthrombotic syndrome, anticoagulation, treatment, prevention
Medical subject headings
Venous Thrombosis, Postthrombotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Also called xarelto

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

  • DiosminDrug

    Also called flebodia

    600 mg q.d. for 12 month

  • compression stockingsOther

    above knee stocking for 12 month

Study groups in NCT03413618
Study groupRoleWhat they receive
Experimental: Rivaroxaban + Diosmin + StockingsExperimentaltreatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin
Receives: Drug: Rivaroxaban; Drug: Diosmin; Other: compression stockings
Control: Rivaroxaban + Stockings onlyActive comparatorstandard treatment of deep vein thrombosis with anticoagulation (rivaroxaban) and elastic compression stockings
Receives: Drug: Rivaroxaban; Other: compression stockings

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (10)

  1. 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

    Measured: 12 months

  2. Number of Participants With Symptomatic Pulmonary Embolism

    detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram

    Measured: 12 months

  3. 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)

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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%.

    Measured: 12 months

  6. 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).

    Measured: 12 months

  7. Adverse Events

    any adverse events detected or suspected

    Measured: 12 months

  8. 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

    Measured: 12 months

  9. 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

    Measured: 12 months

  10. Minor Bleeding

    any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start20 Dec 2017
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized open-labeled clinical trial with a masked outcomes assessor
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413618
Sponsor's protocol ID
RIDILOTT-DVT
Acronym
RIDILOTT-DVT
Status last verified
Jul 2019
First submitted
18 Jan 2018
Last updated
4 Feb 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33201130

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban, Diosmin and compression stockings in people with Deep Vein Thrombosis and Postthrombotic Syndrome, run by Pirogov Russian National Research Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03413618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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