Venous ThromboembolismPhase 4ARTSNCT06523959
Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial
A Phase 4 study testing Apixaban 2.5 MG in people with Venous Thromboembolism and Bleeding, run by Clinical Urology and Epidemiology Working Group at 1 site in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Bleeding
- What is being tested?
- Apixaban 2.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,436 participants
- Where
- 1 siteFinland
- Study dates
- 6 Jun 2024to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent provided
- Adult patients (≥18 years);
- Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
Who cannot join
- 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
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00029
Kari Tikkinen, MD, +358406510530, kari.tikkinen@helsinki.fi
Sara Tornberg, MD, sara.tornberg@hus.fi
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Venous Thromboembolism, Bleeding
- Being tested
- Apixaban 2.5 MG
- Keywords
- angioembolisation, apixaban, bleeding, complications, deep vein thrombosis, direct oral anticoagulant, DOAC, embolisation, evidence-based medicine, gynecology, hemoglobin, hemorrhage, mortality, open label, postoperative, pragmatic, pulmonary embolism, randomized trial, RCT, re-operation
- Medical subject headings
- Venous Thromboembolism, Hemorrhage, Venous Thrombosis, Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 MGDrug
Also called Eliquis 2,5mg
To evaluate the benefits and risks of thromboprophylaxis with oral factor Xa inhibitor Apixaban compared to No anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Apixaban 2.5mg (i.e Eliquis® 2,5mg tablet) orally twice daily for 28 days (with standard of care mechanical prophylaxis) Receives: Drug: Apixaban 2.5 MG |
| No anticoagulation | No intervention | No anticoagulation (with standard of care mechanical prophylaxis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence composite outcome of venous thromboembolism (VTE)
Defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE)
Measured: 90 days
Secondary outcomes (2)
Incidence of symptomatic DVT
Defined as symptomatic deep vein thrombosis
Measured: 90 days
Incidence of symptomatic PE
Defined as symptomatic non-fatal of fatal pulmonary embolism (PE)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start6 Jun 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pragmatic randomized controlled, parallel group, open-label trial with a 1:1 randomization (block randomization) ratio.
- Masking
- None (open label)
- Enrolment
- 5,436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Urology and Epidemiology Working Group
- Sponsor type
- Other government
- Collaborators
- Helsinki University Central Hospital, University of Helsinki, University College, London, Population Health Research Institute, Tabriz University of Medical Sciences, Tampere University Hospital, Turku University Hospital, Oulu University Hospital, North Karelia Central Hospital, Albany Medical College, PaijatHame Central Hospital
- Responsible party
- Principal investigator, Kari Tikkinen, Clinical Urology and Epidemiology Working Group
- Investigators
- Kari AO Tikkinen, Professor, Principal investigator, University of Helsinki and Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523959
- Sponsor's protocol ID
- CLUE-ARTS-2023
- Other IDs
- 2023-508147-43-00, 2023
- Acronym
- ARTS
- Status last verified
- May 2025
- First submitted
- 5 Jul 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06523959
- Acronym / sponsor ID
- ARTS / CLUE-ARTS-2023
- Conditions
- Venous Thromboembolism, Bleeding
- Keywords
- angioembolisation, apixaban, bleeding, complications, deep vein thrombosis, direct oral anticoagulant, DOAC, embolisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,436 participants (estimated)
- Lead sponsor
- Clinical Urology and Epidemiology Working GroupOther government
- Collaborators
- Helsinki University Central Hospital, University of Helsinki, University College, London, Population Health Research Institute, Tabriz University of Medical Sciences, Tampere University Hospital, Turku University Hospital, Oulu University Hospital, North Karelia Central Hospital, Albany Medical College, PaijatHame Central Hospital
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic randomized controlled, parallel group, open-label trial with a 1:1 randomization (block randomization) ratio.
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Apixaban 2.5 MGApixaban 2.5mg (i.e Eliquis® 2,5mg tablet) orally twice daily for 28 days (with standard of care mechanical prophylaxis) |
| No anticoagulation | No intervention | –No anticoagulation (with standard of care mechanical prophylaxis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent provided
- Adult patients (≥18 years);
- Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding
Key exclusion criteria (21 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban 2.5 MGAlso: Eliquis 2,5mgTo evaluate the benefits and risks of thromboprophylaxis with oral factor Xa inhibitor Apixaban compared to No anticoagulation | Drug | Apixaban |
Primary outcome
Incidence composite outcome of venous thromboembolism (VTE)
Time frame: 90 days
Defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE)
2 secondary outcomes
Incidence of symptomatic DVT
Time frame: 90 days
Incidence of symptomatic PE
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kari AO Tikkinen, Professor principal investigator
University of Helsinki and Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban 2.5 MG in people with Venous Thromboembolism and Bleeding, run by Clinical Urology and Epidemiology Working Group at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CLUE Working Group (+358-40-5791034, arts@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence composite outcome of venous thromboembolism (VTE) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.