To show if a combination therapy of rivaroxaban plus Aspirin® is more efficient (superiority testing) as rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy To demonstrate tolerability of combination therapy of Aspirin® plus rivaroxaban in long-term treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Signed informed consent form and data protection declaration obtained prior to any trial-specific procedures
✓. Patient aged ≥18 years
âś“. Confirmed diagnosis of post-thrombotic syndrome defined as Villalta score \> 4 points prior to enrolment and venous stent intervention
âś“. Confirmed stenosis of inferior vena cava, iliac vein, or common femoral vein by duplex ultrasound or cross-sectional imaging (CT venography or MR venography) prior to enrolment and venous stent intervention
âś“. Patients either on active treatment with rivaroxaban or patients planned for treatment with rivaroxaban after intervention
Exclusion criteria
âś•. Previous venous intervention in target vessels
âś•. Any contraindication for antithrombotic therapy (e.g. active gastric ulcer, duodenal ulcer, bleeding disorder with increased tendency of bleedings)
What they're measuring
1
The primary patency rate is defined as the percentage of patients with primary treatment success after 6 months
. Patients with a recent (3 months) clinically significant bleeding and / or active or recent (3 months) ulcerative or inflammatory gastrointestinal disease
âś•. Ongoing antiplatelet therapy or previous antiplatelet therapy within 7 days prior to Visit 1
âś•. Prior stroke or transient ischemic attack (\< 12 months prior to Visit 1)
âś•. Pregnancy, breast feeding, or planned pregnancy within the trial period or women of childbearing potential not using an adequate method of contraception