Venous Thromboembolism study: Apixaban
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 oral medication being studied for preventing blood clots after abdominal or pelvic surgery. Apixaban is designed to inhibit factor Xa, a key enzyme in the blood clotting process.
Also referred to as Eliquis.
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
- The study wants to see if taking apixaban after surgery reduces the risk of blood clots or bleeding compared to not taking any blood thinner.
- Who it's for
- Adults who are having abdominal or pelvic surgery and are not at very high risk for clots or bleeding.
- What's involved
- Participants will either take apixaban or no medication after surgery, and will be followed up with visits and tests to check for clots or bleeding.
- Time commitment
- The study lasts about 30 days after surgery, with a few clinic visits and tests during that time.
- 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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Helsinki, Finland. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.