Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)2025-11-21

Clinical Milestones9View all 9

Results posted 2

2026-06-24Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous ThromboembolismResults posted
2025-11-14Randomized Controlled Trial of Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous ThromboembolismResults posted

Results expected 4

2026-08-19A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)Results expected Q3 2031
2026-06-12STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous ThromboembolismResults expected Q1 2031
2026-02-17Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled StudyResults expected Q3 2030
2026-01-15Statins for Venous Event Reduction in Patients With Venous ThromboembolismResults expected Q1 2028

Recently completed 2

Other updates 1

2026-04-10A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTETerminated

+1 more in the activity timeline below

Industry & Market4View

2026-06-09Aspirin Is Associated With Improved Venous Thromboembolism Prophylaxis Compared With Anticoagulants After Total Hip Arthroplasty in Patients Who Have Prior Hematologic MalignancyIndustry · The Journal of Arthroplasty
2026-03-31Aspirin Is Noninferior to Other Anticoagulants in Low-Risk Patients for Venous Thromboembolism Undergoing Aseptic Revision Total Hip ArthroplastyIndustry · The Journal of Arthroplasty
2026-03-11Is Low-Dose Aspirin the Safest Prophylaxis for Venous Thromboembolism Following Primary Total Hip Arthroplasty?Industry · The Journal of Arthroplasty
2026-02-05Prior Venous Thromboembolism Increases the Risk of Postoperative Thromboembolic Events and Periprosthetic Joint Infection Following Total Knee ArthroplastyIndustry · The Journal of Arthroplasty

Regulatory Updates1View

2025-11-21Approval — RivaroxabanPrevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)

Activity timeline14

2026-08-19ClinicalA 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)Results expected Q3 2031
2026-06-24ClinicalComparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous ThromboembolismResults posted
2026-06-12ClinicalSTAT-CAT: Statin Therapy to Prevent Cancer Associated Venous ThromboembolismResults expected Q1 2031
2026-06-10ClinicalExtended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)Completed
2026-06-09IndustryAspirin Is Associated With Improved Venous Thromboembolism Prophylaxis Compared With Anticoagulants After Total Hip Arthroplasty in Patients Who Have Prior Hematologic MalignancyIndustry · The Journal of Arthroplasty
2026-05-01ClinicalSafety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous ThrombosisCompleted
2026-04-10ClinicalA Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTETerminated
2026-03-31IndustryAspirin Is Noninferior to Other Anticoagulants in Low-Risk Patients for Venous Thromboembolism Undergoing Aseptic Revision Total Hip ArthroplastyIndustry · The Journal of Arthroplasty
2026-03-11IndustryIs Low-Dose Aspirin the Safest Prophylaxis for Venous Thromboembolism Following Primary Total Hip Arthroplasty?Industry · The Journal of Arthroplasty
2026-02-17ClinicalShort-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled StudyResults expected Q3 2030

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies

Rivaroxabanapproved

Approval — Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or k… (2025)

Apixabanapproved

Approval — Adults Prevention of stroke and systemic embolism in adult patients with non-valvula… (2020)

Enoxaparinapproved

Approval — Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly… (2016)

Clinical trials

15 sponsors · 3 new · 3 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme

All trials

Active

Late-stage

Completed

Late-stage studies

STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous Thromboembolism

Phase 4 · Recruiting · Brigham and Women's Hospital

Phase 3 · Recruiting · Regeneron Pharmaceuticals

The DISTINCT Trial: inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT: a National, Multicenter, Randomized, Multi-arm, Open-label Trial.

Phase 4 · Recruiting · Leiden University Medical Center

Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)

Phase 4 · Recruiting · Ottawa Hospital Research Institute

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Phase 3 · Recruiting · Ottawa Hospital Research Institute

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study

Phase 3 · Recruiting · Marc Blondon

Recruiting

STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous Thromboembolism

Phase 4 · Recruiting · Brigham and Women's Hospital

Phase 3 · Recruiting · Regeneron Pharmaceuticals

Phase 4 · Recruiting · Leiden University Medical Center

Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)

Phase 4 · Recruiting · Ottawa Hospital Research Institute

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Phase 3 · Recruiting · Ottawa Hospital Research Institute

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study

Phase 3 · Recruiting · Marc Blondon

Recently completed

Safety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous Thrombosis

Phase 4 · Completed · Ain Shams University

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

Phase 4 · Completed · Ottawa Hospital Research Institute

Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)

Phase 3 · Completed · Sudeep Shivakumar

Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event

Phase 4 · Completed · Yonsei University

Randomized Controlled Trial of Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism

Phase 4 · Completed · Brigham and Women's Hospital

A Phase IV Study on Impact of Edoxaban Treatment in Italian Cancer Patients With Venous Thromboembolism (EDOI Cancer Study) During Antineoplastic Therapy

Phase 4 · Completed · Gruppo Oncologico Italiano di Ricerca Clinica

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals

2025emaApproval — Rivaroxaban· Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) source ↗

2021emaApproval — Rivaroxaban· Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.  Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.  ------ Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.  Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. ------- Adults  Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.   source ↗

2020emaApproval — Rivaroxaban· Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Adults Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. source ↗

2020emaApproval — Apixaban· Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).   Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).   Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults  Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.   Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).   Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).   Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. source ↗

2016emaApproval — Enoxaparin· Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in the extracorporeal circulation during haemodialysis. source ↗

2011emaApproval — Apixaban· Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.  source ↗

2008emaApproval — Rivaroxaban· Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

9 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time

20032025

Most influential

Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC).

European heart journal · 2010 · 3,066 cites

European heart journal · 2009 · 2,203 cites

Circulation · 2024 · 1,692 cites

Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer.

The New England journal of medicine · 2003 · 1,599 cites

Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology.

European heart journal · 2007 · 1,037 cites

Incidence of venous thromboembolism and its effect on survival among patients with common cancers.

Archives of internal medicine · 2006 · 942 cites

Recent publications

Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors.

The New England journal of medicine · 2025 · 78 cites

Circulation · 2024 · 1,692 cites

Characteristics and outcomes of patients hospitalized for COVID-19 and cardiac disease in Northern Italy.

European heart journal · 2020 · 368 cites

A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.

The New England journal of medicine · 2020 · 366 cites

Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC).

European heart journal · 2010 · 3,066 cites

European heart journal · 2009 · 2,203 cites

Major themes8

Atrial Fibrillation2
Antineoplastic Agents1
Cardiology1
Diagnostic Techniques, Cardiovascular1
Hospitalization1
Neuroendocrine Tumors1
Pancreatic Neoplasms1
Thromboembolism1

Leading journals4

European heart journal4
The New England journal of medicine3
Archives of internal medicine1
Circulation1

Leading researchers8

Gorenek B2
Acoba J1
Adamo M1
Al-Attar N1
Alfieri O1
Angelini A1
Armbruster AL1
Atar D1

Affiliations (unnormalised)6

Institute of Cardiology2
University of California2
ACC/AHA Joint Committee on Clinical Data Standards liaison.1
ACC/AHA Joint Committee on Clinical Practice Guidelines liaison.1
Alliance Statistics and Data Management Center1
American College of Clinical Pharmacy representative.1

Related conditions

6 matches

Diseases frequently studied alongside this one. Number shows shared papers.

Atrial Fibrillation4 Hemorrhage3 Heart Diseases2 Heart Failure2 Heart Valve Diseases2 Neoplasms2

Disease profile

A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.

Overview

Thromboembolism is the obstruction of a blood vessel by a blood clot that has formed in the bloodstream and then embolized. It is a vascular occlusive event rather than a single organ-specific disease.

Causes

The supplied grounding identifies a blood clot in the bloodstream as the immediate cause of vessel obstruction. It also links thromboembolism to atrial fibrillation in guideline material, indicating that atrial fibrillation is a clinically relevant source of thromboembolic events.

Pathophysiology

A thrombus forms in the circulation and then travels as an embolus until it lodges in a blood vessel, blocking blood flow. The resulting obstruction produces ischemia in the downstream tissue.

Risk factors

Atrial fibrillation is a relevant risk context in the supplied guideline material because it is associated with thromboembolic events. No other risk factors are supported by the provided grounding.

Current standard of care

The supplied grounding supports anticoagulation as the main treatment class discussed in relation to thromboembolic risk in atrial fibrillation. Beyond that, no specific standard-of-care modalities for thromboembolism are supported by the provided material.

AI-generated summary grounded in MeSH and 1 peer-reviewed source. Informational only — not medical advice. Generated 2026-07-07.

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Identifiers

MeSHThromboembolism

References & data sources

Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
Related entities are derived from literature co-mention (studied together) — associative, not causal.