Status:
TERMINATED
Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
University Hospital Heidelberg
Medical University of Vienna
Conditions:
Venous Thromboses
Stent Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Deep vein thrombosis is associated with severe morbidity and mortality. It is the most frequent type of venous thromboembolism (VTE) and responsible for approximately 800.000 deaths per year in the Eu...
Eligibility Criteria
Inclusion
- Signed informed consent form and data protection declaration obtained prior to any trial-specific procedures
- Patient aged ≥18 years
- Confirmed diagnosis of post-thrombotic syndrome defined as Villalta score \> 4 points prior to enrolment and venous stent intervention
- 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
- Successfully conducted venous stent intervention involving either:
- inferior vena cava
- iliac vein or
- common femoral vein
- Patients either on active treatment with rivaroxaban or patients planned for treatment with rivaroxaban after intervention
Exclusion
- Previous venous intervention in target vessels
- Any contraindication for antithrombotic therapy (e.g. active gastric ulcer, duodenal ulcer, bleeding disorder with increased tendency of bleedings)
- Patients with a recent (3 months) clinically significant bleeding and / or active or recent (3 months) ulcerative or inflammatory gastrointestinal disease
- Ongoing antiplatelet therapy or previous antiplatelet therapy within 7 days prior to Visit 1
- Acute thrombosis (venous thromboembolism events \< 3 months prior to Visit 1)
- Pre-existing coagulopathy
- Prior stroke or transient ischemic attack (\< 12 months prior to Visit 1)
- Pregnancy, breast feeding, or planned pregnancy within the trial period or women of childbearing potential not using an adequate method of contraception
- Severe heart, liver or kidney disease
- Severe somatopathic, neurological and / or psychiatric disease(s)
- Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before Visit 1)
- 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
- Concomitant intake of Methotrexat \> 15 mg per week
- 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
- 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)
- Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- Custody by juridical or official order
- Evidence of an uncooperative attitude
- Difficulties in understanding the language in which the patient information is given
- Patients dependent from the investigator or sponsor (e.g. close relatives of the investigator, employees of the clinic, the sponsor or involved CRO(s))
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04128956
Start Date
March 11 2020
End Date
February 21 2024
Last Update
March 1 2024
Active Locations (6)
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1
Medizinische Universität Wien
Vienna, Austria, 1090
2
Universitätsklinikum der RWTH Aachen
Aachen, Germany, 52074
3
Klinikum Arnsberg - Karolinen Hospital
Arnsberg, Germany, 59759
4
Universitätsklinikum Freiburg
Bad Krozingen, Germany, 79189