Status:
COMPLETED
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Lead Sponsor:
Pirogov Russian National Research Medical University
Conditions:
Deep Vein Thrombosis
Postthrombotic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 postthro...
Eligibility Criteria
Inclusion
- Age over 18 years
- The first episode of femoro-popliteal deep vein thrombosis (DVT)
- Verification of DVT by duplex ultrasound
- Informed consent signed
Exclusion
- 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
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03413618
Start Date
December 20 2017
End Date
July 31 2019
Last Update
February 4 2021
Active Locations (1)
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1
Clinical Hospital no.1 of the President's Administration of Russian Federation
Moscow, Russia, 121352