30 June 2023
News
- Clinical Trials
With HORIZON-HLTH-2022-11-01 funding and under the aegis of INNOVTE, Professor Francis Couturaud will lead an international project at Brest University Hospital in which 8 countries will collaborate. The project's title is MORPHEUS: AMéliORation du Pronostic de la maladie tHrombo-Embolique veineUSe non provoquée au moyen d’un traitement anticoagulant personnalisé.
Venous thromboembolism (VTE) is a frequent and life)-threatening disease. In 50% of cases, VTE occurs in the absence of any major risk factors (unprovoked VTE). In these patients, when anticoagulation is stopped after 3 months of anticoagulation, more than 35% will develop recurrent VTE. Consequently, international guidelines recommend to treat these patients “indefinitely”. However, such practice exposes them to a substantial increase in the risk of bleeding and after several years of anticoagulation in all patients with unprovoked VTE, the risk of anticoagulant-related bleeding is expected to exceed the risk of recurrent VTE after stopping treatment. In addition, extending anticoagulation indefinitely in all patients with unprovoked VTE exposes 65% of patients to an unjustified high risk of bleeding, who would never have experienced recurrent VTE after stopping treatment.
In this setting, optimal duration and management of anticoagulation remains a pivotal and unresolved challenging issue which has the potential to markedly improve long-term prognosis of unprovoked VTE. This treatment optimization requires the development of accurate and discriminant biomarkers that allow to predict both the risk of recurrent VTE after stopping anticoagulant treatment and the risk of anticoagulant-related bleeding in individual patients with unprovoked VTE. These biomarkers should be adaptive on patients’ clinical changes over time, as VTE is a time-dependent disease. Markers related to patients’ preferences and socio-economic factors also have the potential to improve treatment efficiency and adherence during follow-up. Such biomarkers and social markers are currently unavailable or non-validated, which constitutes a major barrier to develop personalized medicine based on individual risk stratification and subsequent shared decision-making for patients and physicians.
The MORPHEUS project is an international program granted by HORIZON-HLTH-2022-TOOL-11-01 call. This project is led by France (Brest University Hospital, INNOVTE network, INSERM) and it includes 8 European countries: France, The Netherlands, Spain, Germany, Switzerland, Poland, Sweden et Denmark.
Based on quantitative and qualitative approaches, MORPHEUS will for the first time integrate (i) clinical, laboratory and imaging biomarkers (personalized medicine) and (ii) socio-anthropological markers (patient-centred model) into sets of prediction rules for optimizing anticoagulant management integrated in a shared decision-making process. The ultimate goal of the European “MORPHEUS” project will be to develop and validate a time-dependent multi-component tool integrated in a shared decision-making process regarding anticoagulant treatment duration in patients with unprovoked VTE. If successful, the whole MORPHEUS program, leaded by a consortium of outstanding European researchers in the field of VTE, will constitute a major breakthrough compared with the present standard of care in patients with unprovoked VTE with major scientific, public health, economic, and societal impacts.
