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

Deep Vein Thrombosis Clinical Trial

— RIDILOTT-DVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413618
• Other study ID #: RIDILOTT-DVT
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2019
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 incidence of post-thrombotic syndrome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban
15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month
• Diosmin
600 mg q.d. for 12 month

Other:
• compression stockings
above knee stocking for 12 month

Locations

Country	Name	City	State
Russian Federation	Clinical Hospital no.1 of the President's Administration of Russian Federation	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

References & 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 Pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months
Secondary	Number of Participants With Symptomatic Pulmonary Embolism	detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram	12 months
Secondary	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)	12 months
Secondary	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.	12 months
Secondary	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%.	12 months
Secondary	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).	12 months
Secondary	Adverse Events	any adverse events detected or suspected	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	Minor Bleeding	any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle	12 months