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

NCT04128956 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-03-01

No results posted yet for this study

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

Interventions

DRUG

Aspirin 100mg

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

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Medical University of Vienna

    collaborator OTHER

  • RWTH Aachen University

    collaborator OTHER

  • Klinikum Arnsberg

    collaborator OTHER

  • University Hospital Freiburg

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Nils Kucher, Prof.Dr.med. · University Hospital, Zürich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2024-02-21
Completion
2024-02-21

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128956 on ClinicalTrials.gov