Avoiding Risks of Thrombosis and Bleeding in Surgery (ARTS) Trial

NCT06523959 | Recruiting Phase 4 DMC

• 2 other identifiers: CLUE-ARTS-20232023-508147-43-00
• Study Type: interventional
• Target: 5,436
• Locations: 1 country
• Sites: 1

Brief 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 sufficiently similar (and not high) risk of venous thromboembolism (VTE) and bleeding that the net impact - benefit or harm - of thromboprophylaxis remains in doubt.

Conditions

Venous Thromboembolism; Bleeding

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; reintervention; surgery; thrombosis; thromboprophylaxis; transfusion; urology; venous thromboembolism; VTE

Outcome Measures

Primary Outcomes (1)

• Incidence composite outcome of venous thromboembolism (VTE)

  Defined as symptomatic deep vein thrombosis (DVT), or symptomatic non-fatal or fatal pulmonary embolism (PE)

  90 days

Secondary Outcomes (2)

• Incidence of symptomatic DVT

  90 days

• Incidence of symptomatic PE

  90 days

Other Outcomes (18)

• Incidence of composite endpoint for major bleeding

  90 days

• Incidence of re-intervention or endovascular embolization to stop bleeding

  90 days

• Incidence of composite outcome of VTE

  30 days

Study Arms (2)

Apixaban

EXPERIMENTAL

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

NO INTERVENTION

No anticoagulation (with standard of care mechanical prophylaxis)

Interventions

Apixaban 2.5 MG DRUG

To evaluate the benefits and risks of thromboprophylaxis with oral factor Xa inhibitor Apixaban compared to No anticoagulation

Also known as: Eliquis 2,5mg

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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, 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
• 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

Sponsors & Collaborators

• Clinical Urology and Epidemiology Working Group: lead
• Helsinki University Central Hospital: collaborator
• University of Helsinki: collaborator
• University College, London: collaborator
• Population Health Research Institute: collaborator
• Tabriz University of Medical Sciences: collaborator
• Tampere University Hospital: collaborator
• Turku University Hospital: collaborator
• Oulu University Hospital: collaborator
• North Karelia Central Hospital: collaborator
• Albany Medical College: collaborator
• PaijatHame Central Hospital: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Hemorrhage; Venous Thrombosis; Pulmonary Embolism; Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Kari AO Tikkinen, Professor

  University of Helsinki and Helsinki University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CLUE Working Group

CONTACT

+358-40-5791034; arts@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology, University of Helsinki and Helsinki University Hospital

Model Details: This is a pragmatic randomized controlled, parallel group, open-label trial with a 1:1 randomization (block randomization) ratio.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 29, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

FI (1)