Overview

Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Zurich
Collaborators:
Klinikum Arnsberg
Medical University of Vienna
RWTH Aachen University
University Hospital Heidelberg
Treatments:
Aspirin
Rivaroxaban
Criteria
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))