Phase 4
Completed N=90
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Deep Vein Thrombosis · Postthrombotic Syndrome
Source: ClinicalTrials.gov NCT03413618 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score — 3; 22 Participants — p=<0.0001
◆ Published Evidence
Established
36citations · ~7 / year
Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled 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.
Linked Publications
-
Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score |
3; 22 | <0.0001 sig |
| SECONDARY Number of Participants With Recurrent Symptomatic or Asymptomatic DVT |
1; 6 | 0.049 sig |
| SECONDARY Number of Participants With Symptomatic Pulmonary Embolism |
0; 0 | — |
| SECONDARY The Value of Venous Clinical Severity Score |
1.2; 4.4 | <0.0001 sig |
| SECONDARY The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items |
22.1; 28.8 | <0.0001 sig |
| SECONDARY Number of Participants With Full Recanalization of the Popliteal Vein |
42; 28 | — |
| SECONDARY Extension of Residual Venous Obstruction by Marder Score |
0.3; 1.9 | 0.001 sig |
| SECONDARY Adverse Events |
5; 4 | 1.000 |
| SECONDARY Major Bleeding |
0; 0 | — |
| SECONDARY Clinically Relevant Non-major Bleeding |
1; 2 | — |
| SECONDARY Minor Bleeding |
2; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03413618) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.