Prognosis Improvement of Unprovoked vEnous THromboEmbolism With the Use of a Shared Decision-making Process Including a Time-dependent Multicomponent Risk Prediction Scores inteRvention.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 37
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Control arm
Anticoagulant treatment management according to usual practice and international guidelines
干预措施: Usual Care Group (Other)
Experimental arm
Shared decision-making process integrating time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI)
干预措施: shared decision-making process (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
- 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)
- Patient's satisfaction(At 18-month follow-up after inclusion)
- Quality of life (QoL) assessed using PembQoL questionnaire(At 18 months after inclusion)
- Quality of life (QoL) assessed using mMRC dyspnea score(At 18 months after inclusion)
- Quality of life (QoL) assessed using VEINQol questionnaire(At 18 months after inclusion)
- Quality of life (QoL) assessed using Villalta score(At 18 months after inclusion)
- Quality of life (QoL) assessed using EQ-5D5L questionnaire(At 18 months after inclusion)
- Quality of life (QoL) assessed using PVFS scale patients(At 18 months after inclusion)
- Therapeutic adherence to anticoagulant treatment(At18-month follow-up after inclusion)
- Occurence of objectively diagnosed cancer: site, localized, locally advanced, metastatic(From inclusion to 18th months follow-up)
- Occurence of minor or atypical venous thrombosis(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(At 18-month follow-up after inclusion)
- Adjudicated objectively confirmed chronic thromboembolic pulmonary disease and chronic thromboembolic pulmonary hypertension(At 18-month follow-up after inclusion)