drugset / Trial / NCT06523959
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
Phase 4
Recruiting
5436 enrolled
Clinical Urology and Epidemiology Working Group
Albany Medical College · collabHelsinki University Central Hospital · collabNorth Karelia Central Hospital · collabOulu University Hospital · collabPaijatHame Central Hospital · collabPopulation Health Research Institute · collabTabriz University of Medical Sciences · collabTampere University Hospital · collabTurku University Hospital · collabUniversity College, London · collabUniversity of Helsinki · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Avoiding Risks of Thrombosis and bleeding in Surgery (ARTS) trial is a pragmatic, international, multicenter, randomized controlled open label trial comparing a direct oral anticoagulant (DOAC) - oral factor Xa inhibitor apixaban - to no anticoagulant among 5,436 patients undergoing abdominal or pelvic surgery at sufficiently similar (and not high) risk of venous thromboembolism (VTE) and bleeding that the net impact - benefit or harm - of thromboprophylaxis remains in doubt.
Timeline
- Start
- 2024-06-06
- Primary completion
- 2028-09-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 2.5 mg | Oral |