Thromboembolic Venous Disease Clinical Trial
Official title:
Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte
The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two clinical manifestations of the
same entity, thromboembolic venous disease. This disease is frequent: the annual incidence of
thromboembolic venous disease estimated between 1 and 2 cases per 1000 inhabitants per year
in France, comparable to that observed in North America. This disease is potentially serious:
the mortality from PE, the most severe manifestation of thromboembolic venous disease (one
third of PE for two thirds of DVT) is 10% at 3 months, twice as high as that of myocardial
infarction. However, the risk of PE in isolated DVT is major (more than 50% of cases). Thus,
whether it is a PE or a DVT, anticoagulant treatment, a cornerstone of therapeutic
management, must therefore be initiated urgently, without waiting for the results of
diagnostic confirmatory examinations.
The major complications occurring after a thromboembolic venous disease are venous
thromboembolic recurrence (VTE) and the long-term consequences: post-thrombotic syndrome and
the development of post-embolic pulmonary hypertension. VTE recurrence has significant
mortality, particularly in the form of PE (15%, compared to 2% in the form of DVT). As for
long-term complications of VTE, about 20-30% of patients with DVT develop post-thrombotic
syndrome at 5 years (27), while 0.15% to 5% of patients with PE develop post-embolic
pulmonary hypertension at 1 year.
While major progress has been made over the past 20 years in terms of diagnosis, primary and
secondary prevention, identification of risk factors for VTE and prognostic factors, however,
two particular subgroups deserve to be specifically investigated: young subjects, whether
women (hormonal exposure) or men (often idiopathic thromboembolic venous disease), and cancer
patients. In the latter, the progress made on anti-cancer treatments is helping to modify the
data on the risk of VTE as well as the duration of treatment of VTE in these patients.
Thus, this prospective cohort covers two subgroups of patients with thromboembolic venous
disease: young subjects (≤50 years) or those who have cancer.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02841085 -
New Genetic Mutations in Thromboembolic Venous Disease Idiopathic. Study "FIT GENETIQUE".
|