Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial

Sponsor
Clinical Urology and Epidemiology Working Group
Study ID
NCT06523959
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bleeding
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apixaban 2.5 MG — DRUG
    To evaluate the benefits and risks of thromboprophylaxis with oral factor Xa inhibitor Apixaban compared to No anticoagulation

Study Details

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.

Key Dates

First listed
Jul 29, 2024
Start date
Jun 6, 2024
Status verified
May 2025
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
5,436 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Incidence composite outcome of venous thromboembolism (VTE) [ Time Frame: 90 days ]

Central Contacts

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