Comparing apixaban to no anticoagulant in surgery patients
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
This study is testing if taking the blood thinner apixaban for 28 days after abdominal or pelvic surgery can help prevent blood clots in patients who are at risk.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 5436 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Urology and Epidemiology Working Group Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT06523959 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective abdominal or pelvic surgery with a similar and not high risk of VTE and bleeding.
Not a fit: Patients with active bleeding, significant risk factors for major bleeding, or those on anticoagulant treatments prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines on the use of anticoagulants in surgical patients, potentially reducing complications related to VTE and bleeding.
How similar studies have performed: Other studies have explored anticoagulant use in surgical settings, but the specific comparison of apixaban in this lower-risk population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Helsinki
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.