Comparing apixaban to no anticoagulant in surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ARTS trial is a large, international, multicenter, randomized controlled trial that evaluates the effectiveness of the direct oral anticoagulant apixaban in preventing venous thromboembolism (VTE) in patients undergoing abdominal or pelvic surgery. It involves 5,436 adult patients at similar risk for VTE and bleeding, comparing those who receive apixaban for 28 days post-surgery to a control group receiving no anticoagulation. The study aims to clarify the balance of benefits and risks associated with pharmacological thromboprophylaxis in this patient population, where the net clinical benefit remains uncertain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* Inability to provide informed consent
* 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

  a. 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
* 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
* Known thrombophilia
* Known bleeding disorder
* Substantial liver impairment (for instance INR 1.4 or more during last 60 days)
* eGRF \<30 mL/min/1.73 m2
* 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
* 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
* Concomitant procedures with high risk of VTE/bleeding
* Previous VTE
* 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
* Previous randomization in this trial
* Any reason why, in the opinion of the investigator(s), the patient should not participate

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting

Study contacts

• Principal investigator: Kari AO Tikkinen, Professor — University of Helsinki and Helsinki University Hospital
• Study coordinator: CLUE Working Group
• Email: arts@hus.fi
• Phone: +358-40-5791034

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.