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

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.

Overview

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.

Interventions

• Other Usual Care Group
  Patients will be managed as regards their anticoagulant treatment according to usual practice and in accordance with international guidelines.
• Other 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-anthropolog

Primary outcome measures

• 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]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Other

Study locations

France · 20 centers

• CHU Brest — Brest
• CHU d'Amiens - Picardie — Amiens
• CHU d'Angers — Angers
• Hôpital National d'Instruction des Armées Percy — Clamart
• CHU de Clermont Ferrand — Clermont-Ferrand
• APHP-Colombes — Colombes
• CHU de Dijon - Hôpital François Mitterand — Dijon
• CH Le Mans — Le Mans
• … and 12 more centers

Identifiers

NCT: NCT06731244 · 29BRC23.0189 · 2024-A01652-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗