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

NCT04128956 | Terminated Phase 2 DMC

• 2 other identifiers: 185242019-001723-12
• Study Type: interventional
• Target: 172
• Locations: 3 countries
• Sites: 6

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 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.

Conditions

Venous Thromboses; Stent Stenosis

Keywords

Aspirin plus rivaroxaban vs. rivaroxaban for the prevention

Outcome Measures

Primary Outcomes (1)

• The primary patency rate is defined as the percentage of patients with primary treatment success after 6 months

  The primary patency rate is defined as the percentage of patients with primary treatment success after 6 months (=Visit 3), i.e. without the occurrence of either i) occlusion of at least a part of the stent segment or ii.) a re-intervention to maintain patency of the treated segment.

  6 month

Secondary Outcomes (8)

• Primary patency rate after 3 months

  3 month

• Secondary patency rate after 3 and 6 months

  3 and 6 months

• Primary sustained clinical success after 3 and 6 months (=Visit 2 and Visit 3)

  3 and 6 months

• Difference between treatment groups in the incidence of patients with open stents but >50% residual stenosis according Duplex criteria

  3 month

• Difference of limb circumference

  3 and 6 months

Study Arms (2)

Aspirin®

EXPERIMENTAL

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.

Drug: Aspirin 100mg

Control group

NO INTERVENTION

Observational study of standard of care anticoagulation (rivarobaban dosis defined in the clinical routine).

Interventions

Aspirin 100mg DRUG

Aspirin® cardio (CH) or Aspirin® protect (DE, AT) Film coated tablets Acetylsalicylic acid 100 mg Once daily oral intake for 6 months

Also known as: Aspirin

Aspirin®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital Heidelberg: collaborator
• Medical University of Vienna: collaborator
• RWTH Aachen University: collaborator
• Klinikum Arnsberg: collaborator
• University Hospital Freiburg: collaborator

Study Sites (6)

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Universitätsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Klinikum Arnsberg - Karolinen Hospital

Arnsberg, 59759, Germany

Location

Universitätsklinikum Freiburg

Bad Krozingen, 79189, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Barco S, Jalaie H, Sebastian T, Wolf S, Fumagalli RM, Lichtenberg M, Zeller T, Erbel C, Schlager O, Kucher N. Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis Among Patients With Post-Thrombotic Syndrome: The Multicenter, Multinational, Randomized, Open-Label ARIVA Trial. Circulation. 2025 Mar 25;151(12):835-846. doi: 10.1161/CIRCULATIONAHA.124.073050. Epub 2025 Jan 28.

  PMID: 39874026 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nils Kucher, Prof.Dr.med.

  University Hospital, Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a multi-center, international, randomized, open label, controlled trial

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: March 11, 2020
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); AU (1); CH (1)