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Taking peoplePhase 4

Apixaban or no blood thinner after abdominal or pelvic surgery to prevent blood clots

Compares apixaban with no blood thinner in adults having abdominal or pelvic surgery.

Key facts

Who runs it
Clinical Urology and Epidemiology Working Group
Where
Finland11 sites in 1 countryChoose a country to see its sites
Registry title
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
Status
Recruiting
Phase
Phase 4
People taking part
5,436 people, planned
Started
6 Jun 2024
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Apixaban 2.5 MG
Record updated
28 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having planned abdominal or pelvic surgery. Their risk of blood clots and of bleeding must be similar and not high. The trial compares apixaban, a blood thinner, with no blood thinner.

Age
18 years and older
Sex
All sexes
Disease stage
Planned (elective) abdominal or pelvic surgery with similar, not high, risk of blood clots in the veins (VTE) and bleeding.
Earlier treatment
No blood thinners, antiplatelet drugs or omega-3 supplements in the 7 days before surgery, and none needed for 30 days after. No chemotherapy, radiation or hormone therapy for cancer in the past 6 months, and none expected within 30 days after surgery.

Main reasons for not taking part

  • Active bleeding in the last 6 months that the planned surgery will not treat, or a condition with a high risk of major bleeding
  • A past blood clot in the veins (VTE), known clotting disorder (thrombophilia) or known bleeding disorder
  • Serious liver problems (for instance INR 1.4 or more in the last 60 days), ALT >2 × upper limit of normal, or eGRF <30 mL/min/1.73 m2
  • Platelet count <100 × 109/L or Hb <90 g/L
  • Pregnant or breast-feeding, or women who had periods in the last 12 months and do not use highly reliable birth control

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Informed consent provided
  • Adult patients (≥18 years)
  • Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding

Who cannot take part

  • Anticoagulant treatment, antiplatelet treatment or omega-3 dietary supplement during previous 7 days preceding surgery and/or requiring within 30 days post-surgery
  • Patient who had during previous 6 months or are expected require within 30 days post-surgery chemotherapy/radiation or hormone therapy for cancer
  • Concomitant procedures with high risk of VTE/bleeding
  • Previous VTE
  • Previous randomization in this trial
  • Patient with active bleeding/hemorrhage during the last 6 months if not expected to be treated by surgery planned
  • Lesion or condition if considered a significant risk factor for major bleeding; This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
  • Known bleeding disorder
  • Known allergy to apixaban
  • Taking strong inhibitors or inductors of both CYP 3A4 and P-glycoprotein, such as anti-seizure medications (e.g. phenytoin, fosphenytoin, carbamazepine), azole-antimycotics (e.g. ketoconazole, itraconazole), HIV-protease inhibitors (e.g. ritonavir, indinavir) and rifampicin
  • Substantial liver impairment (for instance INR 1.4 or more during last 60 days)
  • Platelet count <100 × 109/L (that is, 100 000 mg/L)
  • Hb <90 g/L (that is, <9 g/dL)
  • ALT >2 × upper limit of normal
  • Inability to provide informed consent
  • Known thrombophilia
  • eGRF <30 mL/min/1.73 m2
  • Pregnant or breast-feeding female patients
  • Female participants who have had periods in the last 12 months and who are not using highly reliable contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); iii) intrauterine device (IUD); iv) intrauterine hormone-releasing system (IUS); v) bilateral tubal occlusion; vi) vasectomized partner; and vii) sexual abstinence from heterosexual intercourse during the entire period of risk associated with the study treatments
  • Any reason why, in the opinion of the investigator(s), the patient should not participate

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ApixabanTreatment being tested

    Apixaban 2.5mg (i.e Eliquis® 2,5mg tablet) orally twice daily for 28 days (with standard of care mechanical prophylaxis)

    Treatment: Apixaban 2.5 MG

  • No anticoagulationNo study treatment, for comparison

    No anticoagulation (with standard of care mechanical prophylaxis)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Apixaban or no blood thinner after abdominal or pelvic surgery to prevent blood clotsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
28 May 2025