A Phase 4 interventional study of Apixaban 2.5 MG in Venous Thromboembolism and Bleeding, sponsored by Clinical Urology and Epidemiology Working Group. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Clinical Urology and Epidemiology Working Group · Phase 4, Interventional, and Treatment
Among 37 studies testing apixaban in Venous Thromboembolism — 11 open to participants now, 11 under way, 1 of them phase 3. apixaban · Venous Thromboembolism.
Among the 37 studies testing apixaban in Venous Thromboembolism, this one has the largest planned enrollment, is one of 3 that started in 2024, is one of 14 in phase 4, reaches primary completion later than 8 of the 10 other live ones, and was the 29th registered.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 5,436 is above the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →11 of the 37 studies testing apixaban in Venous Thromboembolism are open now, in 7 countries. Each count lists the studies.
apixaban: first FDA approval 2012 (ELIQUIS), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 113 Venous Thromboembolism studies recruiting now, 90 (80%) set no upper age limit and 13 (12%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →37 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 3 started in 2024.
Median enrollment 100 across the 37 interventional studies. Of the 25 that completed or were terminated, 12 (48%) have results posted.
3 of 37 have an industry lead sponsor. The 10 most frequent:
Clinical Urology and Epidemiology Working Group is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Clinical Urology and Epidemiology Working Group has 1 study filed under Venous Thromboembolism — fewer than ten, so there is no comparison to draw.
7 of the studies testing apixaban in Venous Thromboembolism that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04874428Insel Gruppe AG, University Hospital BernDirect Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis | 2026-12 |
| NCT05683808University of Vermont Medical CenterVenous Thromboembolism Prevention in Outpatients With Glioma | 2026-12-30 |
| NCT07869615Military Hospital of TunisComparison of DOACs and LMWH for Thromboprophylaxis After Total Knee Arthroplasty | 2027-04-15 |
| NCT05735639Imperial College LondonTHRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) | 2027-06-30 |
| NCT06886516Rushad PatellApixaban in Thrombocytopenia | 2027-07-01 |
Among the 37 studies testing apixaban in Venous Thromboembolism, from their registry updates:
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.
Deep vein thrombosis and pulmonary embolism - collectively known as venous thromboembolism VTE - and major bleeding are serious surgical complications leading to poorer patient-reported quality of life and mortality. Pharmacological thromboprophylaxis is an established strategy for reducing VTE risk but balancing it with increased bleeding, particularly after major surgery, poses challenges. Guidelines typically recommend pharmacological thromboprophylaxis for patients at higher, but not lower risk of VTE, without clearly defining procedure or patient selection. There is particular uncertainty regarding the balance of potential benefits and harms of pharmacological thromboprophylaxis in patients who are at a lower estimated risk of VTE postoperatively, in patients with a baseline VTE risk in the range of 2%. In these patients, the risk of major bleeding may be similar to or could potentially outweigh the relatively lower risk of VTE complications, such that the net clinical benefit of routine pharmacological thromboprophylaxis remains unclear.
"Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS)" is a large, randomized, multicenter study, comparing a direct oral anticoagulant (DOAC) called apixaban in patients undergoing abdominal and pelvic surgeries. Half of the 5436 patients will be randomized to receive apixaban after surgery for 28 days with standard of care mechanical prophylaxis - to a control group with no anticoagulation but with standard of care mechanical prophylaxis.
ARTS trial will be the first to compare anticoagulation with DOACs (apixaban) versus no anticoagulation in a population of urologic, gynecologic and abdominal surgical patients. Any of the possible outcomes of 1) A clear net benefit in favor of apixaban or 2) A clear net benefit to not using prophylaxis or 3) a sufficiently close tradeoff that predictive factors and patients' values and preferences regarding bleeding versus thrombosis determines the decision, will substantially enhance evidence-based peri-operative care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apixaban 2.5mg (i.e Eliquis® 2,5mg tablet) orally twice daily for 28 days (with standard of care mechanical prophylaxis)
Drug: Apixaban 2.5 MG
No anticoagulation (with standard of care mechanical prophylaxis)
To evaluate the benefits and risks of thromboprophylaxis with oral factor Xa inhibitor Apixaban compared to No anticoagulation
Also known as: Eliquis 2,5mg
Incidence composite outcome of venous thromboembolism (VTE)
Defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE)
Time frame: 90 days
Incidence of symptomatic DVT
Defined as symptomatic deep vein thrombosis
Time frame: 90 days
Incidence of symptomatic PE
Defined as symptomatic non-fatal of fatal pulmonary embolism (PE)
Time frame: 90 days
Incidence of composite endpoint for major bleeding
Defined as composite endpoint of bleeding leading to a postoperative hemoglobin \<70 g/L, transfusion of ≥1 unit of red blood cells, or bleeding that was judged to be the immediate cause of death
Time frame: 90 days
Incidence of re-intervention or endovascular embolization to stop bleeding
Defined as bleeding requiring re-intervention or endovascular embolization to stop bleeding
Time frame: 90 days
Incidence of composite outcome of VTE
Defined as symptomatic DVT, or symptomatic non-fatal or fatal PE
Time frame: 30 days
Incidence of composite endpoint for major bleeding
Defined as composite endpoint of bleeding leading to a postoperative hemoglobin \<70 g/L, transfusion of ≥1 unit of red blood cells, or bleeding that was judged to be the immediate cause of death
Time frame: 30 days
Incidence of re-intervention or endovascular embolization to stop bleeding
Defined as bleeding requiring re-intervention or endovascular embolization to stop bleeding
Time frame: 30 days
Incidence of symptomatic non-fatal PE
Defined as symptomatic non-fatal pulmonary embolism
Time frame: 90 days
Incidence of symptomatic fatal PE
Defined as fatal pulmonary embolism
Time frame: 90 days
Incidence of bleeding leading to a postoperative hemoglobin <70 g/L
Time frame: 90 days
Incidence of transfusion of ≥1 unit of red blood cells
Time frame: 90 days
Incidence of bleeding that was judged to be the immediate cause of death
Time frame: 90 days
Incidence of bleeding requiring re-intervention to stop bleeding
Time frame: 90 days
Incidence of bleeding requiring endovascular embolization to stop bleeding
Time frame: 90 days
Overall mortality
Time frame: 90 days
Incidence of SUSARs potentially related to the study drug (apixaban)
Time frame: 90 days
Incidence of Serious Adverse Events (SAEs), any
Time frame: 90 days
Incidence of any potentially drug-related SAEs (serious), cardiac complications, cerebral complications, infectious complications, admittance to intensive care, reoperation or other intervention for other reason than bleeding and other complication
Time frame: 90 days
Incidence of critical organ bleeding
Time frame: 90 days
Cost-effectiveness of DOAC administration
The trial will also assess the cost-effectiveness of apixaban administration compared to no pharmacological thromboprophylaxis. An extended time horizon decision analytic model will evaluate the costs associated with VTE and bleeding events in both trial arms. Based on these analyses, the additional or saved costs per quality- adjusted life-year (QALY) will be determined for various trial outcomes, including scenarios where apixaban is superior to no pharmacological thromboprophylaxis or vice versa. Costs will be evaluated from the perspective of national health service in selected countries. This assessment will consider patient healthcare resource utilisation, staff training costs (e.g., administering subcutaneous injections), and medication costs. The benefits of the interventions will be measured in terms of clinical outcomes, such as the reduction in VTE events and complications (including VTE and bleeding events). Additionally, QoL information will be used to calculate QALYs.
Time frame: 90 days
Plan to share: Yes — The research data needed to validate the results presented in the deposited scientific publications are deposited and the data of individual participants is made available to the research community. Incase the publication would mean disclosing information relating to the Party's Confidential Information the Parties shall negotiate how to modify the publication in order to remove such Confidential Information from the publication. In case the publication would prevent a Party from securing its Intellectual Property Rights the publication shall be postponed until the rights have been secured.
Time frame: Not longer than sixty (60) days from the claim made to restrict the publication.
Access criteria: If the Parties have not expressed their well-founded and specified claim to restrict the publication within the said time limit, the publication shall be considered permitted.
No publications or documents are linked to this record.
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Studies of the drug tested here: Apixaban
Clinical Urology and Epidemiology Working Group