Shared Decision-making Process for Unprovoked vEnous THromboEmbolism Management. (ETHER )

NCT06731244 | Recruiting DMC

• 2 other identifiers: 29BRC23.01892024-A01652-45
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 20

Brief Summary

Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) is a frequent disease and the third most common cause of cardiovascular death in the world after myocardial infarction and stroke. Anticoagulant therapy drastically reduces the risk of early VTE recurrence and death, but it exposes patients to a substantial risk of bleeding. Hence, determining the optimal duration of anticoagulant treatment for VTE is a major public health issue. When major transient risk factors for VTE are identified (major surgery, immobilization...), patients generally do not need to extend anticoagulation beyond 3 months, whereas for VTE diagnosed in the context of cancer, therapeutic anticoagulation is required for as long as the cancer is considered "active". However, in more than 50% of cases, venous thromboembolic disease occurs spontaneously, i.e. without any significant clinically detectable circumstance (known as unprovoked venous thromboembolic disease). In such patients, the risk of recurrence is high (35% recurrence rate at 5 years, with a 10% risk of death per recurrence). Scientific societies therefore recommend continuing anticoagulant treatment "indefinitely" (i.e. without programming a stop date or long-term treatment). However, this practice exposes these patients to an ongoing, non-negligible increase in the risk of bleeding, which could ultimately exceed the risk of recurrence of venous thrombo-embolic disease. Optimizing anticoagulant therapy beyond the first three to six months of treatment is therefore a crucial and challenging issue, which could improve the long-term prognosis of patients with unprovoked thromboembolic venous disease. Based on the quantitative and qualitative approaches implemented in MORPHEUS project granted by European Commission (HORIZON-HLTH-2022-TOOL-11-01 call), the investigators have combined predictive personalized medicine, through the use of risk biomarkers, with a patient-centered model of medicine, which, while based on an understanding of the patient's experience, leading to develop Time-Dependent Multicomponent risk prediction scores and socIo-anthropological scales (TDMI) integrated in a shared decision-making process regarding anticoagulant treatment duration in patients with a first episode of unprovoked VTE. The aim of this study is to demonstrate that this strategy, based on a medical decision-making process shared between patients and physicians and including TDMI, reduces the risk of recurrence of thromboembolic venous disease (fatal or non-fatal), the risk of bleeding and all-cause mortality, and is associated with greater patient satisfaction after a first episode of unprovoked thromboembolic venous disease.

Conditions

Venous Thromboembolism

Keywords

venous thrombosis; pulmonary embolism; Anticoagulant; deep vein thrombosis; stepped-wedge cluster randomized trial; shared-decision making

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite of adjudicated all-cause mortality, adjudicated symptomatic recurrent VTE (fatal or non-fatal PE or proximal DVT), adjudicated major and clinically relevant non-major bleeding, and patient's satisfaction

  For the statistical analysis, the investigators will analyse hierarchically each component of the composite (all-cause mortality, then VTE recurrence, then major bleeding or clinically relevant non-major bleeding and then patient's satisfaction in this order) using a win ratio approach to assess the primary composite outcome.

  From inclusion to 18th month follow-up

Secondary Outcomes (17)

• Composite of adjudicated all-cause mortality, symptomatic recurrent VTE (fatal or non-fatal PE or proximal DVT) and major and clinically relevant non-major bleeding

  At 18-month follow-up after inclusion

• Adjudicated all-cause mortality,

  At 18 months follow-up after inclusion

• Adjudicated symptomatic VTE recurrence

  At 18-month follow-up after inclusion

• Adjudicated major bleeding or clinically relevant non-major bleeding

  At 18-month follow-up after inclusion

• Adjudicated fatal recurrent VTE and fatal bleeding

  At 18-month follow-up after inclusion

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Anticoagulant treatment management according to usual practice and international guidelines

Other: Usual Care Group

Experimental arm

EXPERIMENTAL

Shared decision-making process integrating time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI)

Other: shared decision-making process

Interventions

Usual Care Group OTHER

Patients will be managed as regards their anticoagulant treatment according to usual practice and in accordance with international guidelines.

Control arm

shared decision-making process OTHER

The intervention is based on a strategy based on a shared decision-making process which is a collaborative process that involves a patient and their healthcare professional working together to reach a joint decision about care (anticoagulant treatment). The shared decision-making process will be conducted as follows: * Step 1: prepare the risk estimates (risk of recurrent VTE, risk of bleeding) for the patient, based on time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI) and other validated risk prediction scores and evidence-based medicine; * Step 2: Communicating risks, benefits and consequences to the patient; * Step 3: Make a joint decision about treatment and care, and agree together when this will be reviewed.

Experimental arm

Eligibility Criteria

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

You may qualify if:

• Patient \> or = 18 years,
• Patient with a first episode of symptomatic unprovoked pulmonary embolism (PE) and/or proximal deep vein thrombosis (DVT) treated for 3 to 6 uninterrupted months with full dose anticoagulant therapy,
• Signed informed consent.

You may not qualify if:

• Unable or refusal to give informed consent,
• Isolated distal DVT,
• Isolated sub-segmental PE
• Previous unprovoked VTE
• Known CTEPH
• Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves…),
• Active cancer of less than 24 months,
• Current pregnancy,
• Life expectancy \<18 months (e.g.; patients with an end-stage chronic disease)
• Not affiliated to national insurance, social security (only for France)

Sponsors & Collaborators

• University Hospital, Brest: lead
• European Commission: collaborator
• European Clinical Research Infrastructure Network: collaborator

Study Sites (20)

CHU Brest

Brest, France, 29609, France

RECRUITING

CHU d'Amiens - Picardie

Amiens, 80054, France

NOT YET RECRUITING

CHU d'Angers

Angers, 49933, France

NOT YET RECRUITING

Hôpital National d'Instruction des Armées Percy

Clamart, 92140, France

NOT YET RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

APHP-Colombes

Colombes, 92700, France

NOT YET RECRUITING

CHU de Dijon - Hôpital François Mitterand

Dijon, 21079, France

NOT YET RECRUITING

CH Le Mans

Le Mans, 72037, France

NOT YET RECRUITING

HCL - Hôpital Edouard Herriot

Lyon, 69003, France

NOT YET RECRUITING

APHM - Hôpital la Timone

Marseille, 13005, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, 34295, France

NOT YET RECRUITING

CHU de Nancy

Nancy, 54511, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

NOT YET RECRUITING

CHU de Nîmes

Nîmes, 30029, France

NOT YET RECRUITING

Aphp-Hegp

Paris, 75015, France

NOT YET RECRUITING

Aphp-Hegp

Paris, 75015, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35200, France

NOT YET RECRUITING

CHU Saint Etienne

Saint-Etienne, 42270 Saint Priest En Jarez, France

NOT YET RECRUITING

CHU de Strasbourg

Strasbourg, 67091, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Central Study Contacts

Francis COUTURAUD, Prof.

CONTACT

+33298347348; francis.couturaud@chu-brest.fr

Hélène FORTIN-PRUNIER

CONTACT

+33221744115; helene.fortin-prunier@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ETHER is a stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: December 12, 2024
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2035
• Study Completion (Estimated): October 1, 2035
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

FR (20)