Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial: An International Randomised Controlled Trial Evaluating Apixaban Versus No Anticoagulation in Patients Undergoing General Abdominal, Gynecologic and Urologic Surgery
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Informed consent provided
• Adult patients (≥18 years);
• Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Contact Information
Primary
CLUE Working Group
arts@hus.fi
+358-40-5791034
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 5436
Treatments
Experimental: Apixaban
Apixaban 2.5mg (i.e Eliquis® 2,5mg tablet) orally twice daily for 28 days (with standard of care mechanical prophylaxis)
No_intervention: No anticoagulation
No anticoagulation (with standard of care mechanical prophylaxis)
Related Therapeutic Areas
Sponsors
Collaborators: Population Health Research Institute, Tabriz University of Medical Sciences, Oulu University Hospital, Tampere University Hospital, University of Helsinki, Helsinki University Central Hospital, Turku University Hospital, Albany Medical College, University College, London, PaijatHame Central Hospital, North Karelia Central Hospital
Leads: Clinical Urology and Epidemiology Working Group