BridgeMD
New treatment option for Venous Thromboembolism
Official title Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
ClinicalTrials.gov ID: NCT06523959
What this study is testing
What is Apixaban 2.5 MG?
Apixaban 2.5 MG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for venous thromboembolism.
Also referred to as Eliquis 2,5mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent provided
- Adult patients (≥18 years);
- Undergoing elective 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
- 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...
- Anticoagulant treatment, antiplatelet treatment or omega-3 dietary supplement during previous 7 days preceding surgery and/or requiring within 30...
- 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
See the full eligibility criteria
- Informed consent provided
- Adult patients (≥18 years);
- Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
- 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...
- 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)...
- 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...
- Previous randomization in this trial
- Any reason why, in the opinion of the investigator(s), the patient should not participate
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland. 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 ClinicalTrials.gov; the study team decides eligibility.