Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial

18524

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.

2020-03-11

2024-02-21

2024-02-21

Terminated

Early phase I

172

Inclusion Criteria: 1. Signed informed consent form and data protection declaration obtained prior to any trial-specific procedures 2. Patient aged ≥18 years 3. Confirmed diagnosis of post-thrombotic syndrome defined as Villalta score \> 4 points prior to enrolment and venous stent intervention 4. 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 5. Successfully conducted venous stent intervention involving either: * inferior vena cava * iliac vein or * common femoral vein 6. Patients either on active treatment with rivaroxaban or patients planned for treatment with rivaroxaban after intervention Exclusion Criteria: 1. Previous venous intervention in target vessels 2. Any contraindication for antithrombotic therapy (e.g. active gastric ulcer, duodenal ulcer, bleeding disorder with increased tendency of bleedings) 3. Patients with a recent (3 months) clinically significant bleeding and / or active or recent (3 months) ulcerative or inflammatory gastrointestinal disease 4. Ongoing antiplatelet therapy or previous antiplatelet therapy within 7 days prior to Visit 1 5. Acute thrombosis (venous thromboembolism events \< 3 months prior to Visit 1) 6. Pre-existing coagulopathy 7. Prior stroke or transient ischemic attack (\< 12 months prior to Visit 1) 8. Pregnancy, breast feeding, or planned pregnancy within the trial period or women of childbearing potential not using an adequate method of contraception 9. Severe heart, liver or kidney disease 10. Severe somatopathic, neurological and / or psychiatric disease(s) 11. Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before Visit 1) 12. Known hypersensitivity to acetylsalicylic acid (Aspirin® cardio or Aspirin® protect and / or its excipients), to other antiphlogistic drugs or to analgesics or anti-fever drugs 13. Concomitant intake of Methotrexat \> 15 mg per week 14. Parallel participation in another clinical trial, participation in a clinical trial within less than 6 weeks prior to the Screening visit or previous participation in this clinical trial 15. Known to be, or suspected of being unable to comply with the trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) 16. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study 17. Custody by juridical or official order 18. Evidence of an uncooperative attitude 19. Difficulties in understanding the language in which the patient information is given 20. Patients dependent from the investigator or sponsor (e.g. close relatives of the investigator, employees of the clinic, the sponsor or involved CRO(s))

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2024-03-01