Venous ThromboembolismETHERNCT06731244
Shared Decision-making Process for Unprovoked vEnous THromboEmbolism Management. (ETHER )
A study testing shared decision-making process in people with Venous Thromboembolism, run by University Hospital, Brest at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- shared decision-making process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 20 sitesFrance
- Study dates
- 30 Oct 2025to Oct 2035
- Phase
- Interventional
- 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
- 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.
Who cannot join
- 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…),
Show all 11Show fewer
- 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)
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Not yet recruiting
CHU d'Amiens - Picardie
Amiens, 80054
Marie-Antoinette SEVESTRE, Dr., + 33322087306, sevestre.marie-antoinette@chu-amiens.fr
- Not yet recruiting
CHU d'Angers
Angers, 49933
Jeanne HERSANT, Dr., +33241353689, Jeanne.Hersant@chu-angers.fr
- Recruiting
CHU Brest
Brest, France, 29609
Francis COUTURAUD, Prof, +33298347348, francis.couturaud@chu-brest.fr
- Not yet recruiting
Hôpital National d'Instruction des Armées Percy
Clamart, 92140
Caroline DOUTRELON, Dr., +33141466252, caroline.doutrelon@intradef.gouv.fr
- Not yet recruiting
CHU de Clermont Ferrand
Clermont-Ferrand, 63000
Jeannot SCHMIDT, Prof., +33473754549, jschmidt@chu-clermontferrand.fr
- Not yet recruiting
APHP-Colombes
Colombes, 92700
Isabelle MAHE, Prof., +33147606490, isabelle.mahe@aphp.fr
- Not yet recruiting
CHU de Dijon - Hôpital François Mitterand
Dijon, 21079
Nicolas FALVO, Dr., +33380295586, nicolas.falvo@chu-dijon.fr
- Not yet recruiting
CH Le Mans
Le Mans, 72037
Claire NEVEUX, Dr., +33243434343, cneveux@ch-lemans.fr
- Not yet recruiting
HCL - Hôpital Edouard Herriot
Lyon, 69003
Judith CATELLA, Dr., +33472117791, judith.catella@chu-lyon.fr
- Not yet recruiting
APHM - Hôpital la Timone
Marseille, 13005
Gabrielle SARLON BARTOLI, Dr., +33491387023, gabrielle.sarlon@ap-hm.fr
- Not yet recruiting
CHU de Montpellier
Montpellier, 34295
Isabelle QUERE, Prof., +33467337025, i-quere@chu-montpellier.fr
- Not yet recruiting
CHU de Nancy
Nancy, 54511
Stéphane ZUILY, Prof., +33383153614, s.zuily@chru-nancy.fr
- Not yet recruiting
CHU de Nantes
Nantes, 44093
Jérôme CONNAULT, Dr., +33240083848, jerome.connault@chu-nantes.fr
- Not yet recruiting
CHU de Nîmes
Nîmes, 30029
Valérie RAY, Dr., +33466685131, valerie.ray@chu-nimes.fr
- Not yet recruiting
Aphp-Hegp
Paris, 75015
Olivier SANCHEZ, Prof., +33156093487, olivier.sanchez@aphp.fr
- Not yet recruiting
Aphp-Hegp
Paris, 75015
Lina Khider, Dr., +33156093077, lina.khider@aphp.fr
- Not yet recruiting
CHU de Rennes
Rennes, 35200
Alice BALLERIE, Prof., +33299284321, alice.ballerie@chu-rennes.fr
- Not yet recruiting
CHU Saint Etienne
Saint-Etienne, 42270 Saint Priest En Jarez
Laurent BERTOLETTI, Prof., + 33477127596, laurent.bertoletti@chu-st-etienne.fr
- Not yet recruiting
CHU de Strasbourg
Strasbourg, 67091
Dominique STEPHAN, Prof., +33369550952, Dominique.Stephan@chru-strasbourg.fr
- Not yet recruiting
CHU de Toulouse
Toulouse, 31000
Alessandra BURA-RIVIERE, Prof., +33561322448, bura-riviere.a@chu-toulouse.fr
About this study
Official title: Prognosis Improvement of Unprovoked vEnous THromboEmbolism With the Use of a Shared Decision-making Process Including a Time-dependent Multicomponent Risk Prediction Scores inteRvention.
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".
Read more
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
- Being tested
- Usual Care Group, shared decision-making process
- Keywords
- venous thrombosis, pulmonary embolism, Anticoagulant, deep vein thrombosis, stepped-wedge cluster randomized trial, shared-decision making
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care GroupOther
Patients will be managed as regards their anticoagulant treatment according to usual practice and in accordance with international guidelines.
shared decision-making processOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Anticoagulant treatment management according to usual practice and international guidelines Receives: Other: Usual Care Group |
| Experimental arm | Experimental | Shared decision-making process integrating time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI) Receives: Other: shared decision-making process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This clinical composite outcome will be compared between the intervention group and the control group at the individual level with a mixed effect cox model with a random intercept to account for the correlation between patients of a same cluster. The random intercept will correspond to a random period effect nested in a random cluster effect. Different covariance structure will be tested, the model will be selected as the best identifiable model that produces the lowest Bayesian Information Criterion (BIC) value. The effect of the intervention (shared decision-making process including a TDMI) will be then presented as the hazard ratio between the two groups of treatment and its corresponding 95% CI. A random cluster effect will be added to the treatment group effect, if necessary, to quantify any heterogeneity in the benefit of the intervention. The superiority test on this outcome will be performed only if the primary outcome is statistically demonstrated.
Measured: At 18-month follow-up after inclusion
Adjudicated all-cause mortality,
Measured: At 18 months follow-up after inclusion
Adjudicated symptomatic VTE recurrence
Measured: At 18-month follow-up after inclusion
Adjudicated major bleeding or clinically relevant non-major bleeding
Measured: At 18-month follow-up after inclusion
Adjudicated fatal recurrent VTE and fatal bleeding
Measured: At 18-month follow-up after inclusion
Patient's satisfaction
Patient's satisfaction will be defined with the Patient Activation Measure - PAM score using 13 items measures that assess patient's knowledge, skill, and confidence for self-management. The scoring (for each criteria) is:
- Strongly disagree = 1
- Disagree = 2
- Agree = 3
- Strongly agree = 4
Measured: At 18-month follow-up after inclusion
Quality of life (QoL) assessed using PembQoL questionnaire
Evaluation only for patients with symptomatic PE. The PEmb-QoL Score is ranged between 0% and 100% for each of its 6 dimensions. Higher scores indicate worse outcome.
Measured: At 18 months after inclusion
Quality of life (QoL) assessed using mMRC dyspnea score
Evaluation only for patients with symptomatic PE. Scale ranged from 0 (no dyspnea) to 5 (worst grade)
Measured: At 18 months after inclusion
Quality of life (QoL) assessed using VEINQol questionnaire
Evaluation only for patients with symptomatic DVT. Responses are rated on two-point to seven-point Likert response scales of intensity, frequency, or agreement.
Measured: At 18 months after inclusion
Quality of life (QoL) assessed using Villalta score
Evaluation only for patients with symptomatic DVT. The total Villalta score, ranging from 0 to 33, will be assessed in both legs and used to categorize the severity of PTS in the index leg as mild (score, 5-9), moderate (score, 10-14), or severe (score, ≥15 or presence of ulceration).
Measured: At 18 months after inclusion
Quality of life (QoL) assessed using EQ-5D5L questionnaire
Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels. The patient is asked to indicate his/her health state.
Measured: At 18 months after inclusion
Quality of life (QoL) assessed using PVFS scale patients
Scale ranged from 0 (normal functional status) to 5 (worse grade)
Measured: At 18 months after inclusion
Therapeutic adherence to anticoagulant treatment
Therapeutic adherence using Girerd's questionnaire: 6 items. Score 0 = good compljance ; Score 1-2 = minor concern in compliance ; Score ≥ 3 = bad compliance.
Measured: At18-month follow-up after inclusion
Occurence of objectively diagnosed cancer: site, localized, locally advanced, metastatic
Cancers will be classified according the site and the extend (localized, locally advanced, metastatic).
Measured: From inclusion to 18th months follow-up
Occurence of minor or atypical venous thrombosis
Minor venous thrombosis includes superficial vein thrombosis, muscular and distal deep vein thrombosis. Atypical venous thrombosis includes: Proximal upper limbs Superior vena cava, Cerebral venous thrombosis, Portal thrombosis, Mesenteric thrombosis, Sus-hepatic vein thrombosis, Renal thrombosis, Ovarian vein thrombosis, Uterine vein thrombosis, Retinal vein thrombosis.
Measured: At 18-month follow-up after inclusion
Adjudicated objectively diagnosed acute arterial thromboembolic events according to international guidelines: stroke, myocardial infarction, peripheral arterial thromboembolic event, atrial fibrillation, any cardiac event other than VTE
Measured: At 18-month follow-up after inclusion
Adjudicated objectively confirmed chronic thromboembolic pulmonary disease and chronic thromboembolic pulmonary hypertension
Measured: At 18-month follow-up after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start30 Oct 2025
- Primary completionOct 2035 (estimated)
- Study completionOct 2035 (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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- ETHER is a stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, European Clinical Research Infrastructure Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731244
- Sponsor's protocol ID
- 29BRC23.0189
- Other IDs
- 2024-A01652-45
- Acronym
- ETHER
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Improvement of Unprovoked vEnous THromboEmbolism With the Use of a Shared Decision-making Process Including a Time-dependent Multicomponent Risk Prediction Scores inteRvention.
- ClinicalTrials.gov ID
- NCT06731244
- Acronym / sponsor ID
- ETHER / 29BRC23.0189
- Conditions
- Venous Thromboembolism
- Keywords
- venous thrombosis, pulmonary embolism, Anticoagulant, deep vein thrombosis, stepped-wedge cluster randomized trial, shared-decision making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- European Commission, European Clinical Research Infrastructure Network
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Oct 2035 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 12 Dec 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ETHER is a stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Usual Care GroupAnticoagulant treatment management according to usual practice and international guidelines |
| Experimental arm | Experimental | Other: shared decision-making processShared decision-making process integrating time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Unable or refusal to give informed consent,
- Isolated distal DVT,
- Isolated sub-segmental PE
- Previous unprovoked VTE
- Known CTEPH
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 |
|---|---|---|
| Usual Care GroupPatients will be managed as regards their anticoagulant treatment according to usual practice and in accordance with international guidelines. | Other | Control arm |
| shared decision-making processThe 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. | Other | Experimental arm |
Primary outcome
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
Time frame: From inclusion to 18th month follow-up
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.
17 secondary outcomes
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
Time frame: At 18-month follow-up after inclusion
Adjudicated all-cause mortality,
Time frame: At 18 months follow-up after inclusion
Adjudicated symptomatic VTE recurrence
Time frame: At 18-month follow-up after inclusion
Adjudicated major bleeding or clinically relevant non-major bleeding
Time frame: At 18-month follow-up after inclusion
Adjudicated fatal recurrent VTE and fatal bleeding
Time frame: At 18-month follow-up after inclusion
Patient's satisfaction
Time frame: At 18-month follow-up after inclusion
Quality of life (QoL) assessed using PembQoL questionnaire
Time frame: At 18 months after inclusion
Quality of life (QoL) assessed using mMRC dyspnea score
Time frame: At 18 months after inclusion
Quality of life (QoL) assessed using VEINQol questionnaire
Time frame: At 18 months after inclusion
Quality of life (QoL) assessed using Villalta score
Time frame: At 18 months after inclusion
Quality of life (QoL) assessed using EQ-5D5L questionnaire
Time frame: At 18 months after inclusion
Quality of life (QoL) assessed using PVFS scale patients
Time frame: At 18 months after inclusion
Therapeutic adherence to anticoagulant treatment
Time frame: At18-month follow-up after inclusion
Occurence of objectively diagnosed cancer: site, localized, locally advanced, metastatic
Time frame: From inclusion to 18th months follow-up
Occurence of minor or atypical venous thrombosis
Time frame: At 18-month follow-up after inclusion
Adjudicated objectively diagnosed acute arterial thromboembolic events according to international guidelines: stroke, myocardial infarction, peripheral arterial thromboembolic event, atrial fibrillation, any cardiac event other than VTE
Time frame: At 18-month follow-up after inclusion
Adjudicated objectively confirmed chronic thromboembolic pulmonary disease and chronic thromboembolic pulmonary hypertension
Time frame: At 18-month follow-up after inclusion
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 Nov 2025.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shared decision-making process in people with Venous Thromboembolism, run by University Hospital, Brest at 20 sites in France.
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 11 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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.
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 Francis COUTURAUD, Prof. (+33298347348, francis.couturaud@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From inclusion to 18th month follow-up). 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 Nov 2025.