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Avoiding Risks of Thrombosis and bleeding in Surgery (ARTS) trial
EU CTIS ID: 2023-508147-43-00
What this study is testing
To evaluate the benefits and risks of thromboprophylaxis with apixaban (oral factor Xa inhibitor) DOAC therapy (with standard of care mechanical thromboprophylaxis) compared with no anticoagulant (with standard of care mechanical thromboprophylaxis) for patients undergoing urologic, gynecologic, and general abdominal surgery procedures, where patients are at sufficiently similar (and not high) risks of VTE and bleeding such that the net impact of pharmacological thromboprophylaxis remains uncertain
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent
- Adult patients (≥18 years) at screening
- Undergoing abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
You likely can't join if
- Inability to provide informed consent
- Platelet count <100 × 109/L (that is, 100 000 mg/L)
- Hb <90 g/L (that is, <9 g/dL)
- ALT >2 times 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
See the full eligibility criteria
- Informed consent
- Adult patients (≥18 years) at screening
- Undergoing abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
- Inability to provide informed consent
- Platelet count <100 × 109/L (that is, 100 000 mg/L)
- Hb <90 g/L (that is, <9 g/dL)
- ALT >2 times 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
- Patient with active bleeding/hemorrhage during the last 6 months if not expected to be treated by surgery planned
- Any reason why, in the opinion of the investigator(s), the patient should not participate
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- Iran, Islamic Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; Iran, Islamic Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.