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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2035-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

ETHER is a stepped wedge cluster randomized trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control arm

Anticoagulant treatment management according to usual practice and international guidelines

Group Type ACTIVE_COMPARATOR

Usual Care Group

Intervention Type OTHER

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

Experimental arm

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

Group Type EXPERIMENTAL

shared decision-making process

Intervention Type 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.

Interventions

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shared decision-making process

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.

Intervention Type OTHER

Usual Care Group

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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…),
* Interruption of anticoagulation for 14 days or more before the inclusion,
* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Brest

Brest, France, France

Site Status RECRUITING