Prognosis Improvement of Unprovoked vEnous THromboEmbolism With the Use of a Shared Decision-making Process Including a Time-dependent Multicomponent Risk Prediction Scores inteRvention.

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU d'Amiens - Picardie
NOT_YET_RECRUITING
Amiens
CHU d'Angers
NOT_YET_RECRUITING
Angers
CHU Brest
RECRUITING
Brest
Hôpital National d'Instruction des Armées Percy
NOT_YET_RECRUITING
Clamart
CHU de Clermont Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
APHP-Colombes
NOT_YET_RECRUITING
Colombes
CHU de Dijon - Hôpital François Mitterand
NOT_YET_RECRUITING
Dijon
CH Le Mans
NOT_YET_RECRUITING
Le Mans
HCL - Hôpital Edouard Herriot
NOT_YET_RECRUITING
Lyon
APHM - Hôpital la Timone
NOT_YET_RECRUITING
Marseille
CHU de Montpellier
NOT_YET_RECRUITING
Montpellier
CHU de Nancy
NOT_YET_RECRUITING
Nancy
CHU de Nantes
NOT_YET_RECRUITING
Nantes
CHU de Nîmes
NOT_YET_RECRUITING
Nîmes
Aphp-Hegp
NOT_YET_RECRUITING
Paris
Aphp-Hegp
NOT_YET_RECRUITING
Paris
CHU de Rennes
NOT_YET_RECRUITING
Rennes
CHU Saint Etienne
NOT_YET_RECRUITING
Saint-etienne
CHU de Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Francis COUTURAUD, Prof.
francis.couturaud@chu-brest.fr
+33298347348
Backup
Hélène FORTIN-PRUNIER
helene.fortin-prunier@chu-brest.fr
+33221744115
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2028-10
Participants
Target number of participants: 2400
Treatments
Active_comparator: Control arm
Anticoagulant treatment management according to usual practice and international guidelines
Experimental: Experimental arm
Shared decision-making process integrating time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI)
Sponsors
Collaborators: European Clinical Research Infrastructure Network, European Commission
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov