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

Browse trials for

• Venous Thrombosis 785Registry's first term
• Postthrombotic Syndrome 73Primary · reclassified

Keywords

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

Postthrombotic Syndrome Reclassified

73 studies on the registry are indexed under Postthrombotic Syndrome; 21 are open to participants now.

This study's enrollment of 90 is close to the median of 95 across 46 interventional studies indexed under Postthrombotic Syndrome.

Lead sponsor

Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.

Study arms

• Experimental
  Experimental: Rivaroxaban + Diosmin + Stockings

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

  Drug: Rivaroxaban · Drug: Diosmin · Other: compression stockings

• Active comparator
  Control: Rivaroxaban + Stockings only

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

  Drug: Rivaroxaban · Other: compression stockings

Interventions

• DrugRivaroxaban

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

  Also known as: xarelto

• DrugDiosmin

  600 mg q.d. for 12 month

  Also known as: flebodia

• Othercompression stockings

  above knee stocking for 12 month

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.

   Time frame: 12 months

Secondary outcomes

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

   Time frame: 12 months

2. Number of Participants With Symptomatic Pulmonary Embolism

   detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram

   Time frame: 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)

   Time frame: 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.

   Time frame: 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%.

   Time frame: 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).

   Time frame: 12 months

7. Adverse Events

   any adverse events detected or suspected

   Time frame: 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

   Time frame: 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

   Time frame: 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

    Time frame: 12 months

Baseline characteristics

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 ↗

Study documents

• Protocol and statistical analysis plan ↗ · Nov 11, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No