Calendario›SNY›Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin
Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin
Ensayo de Sanofi en Venous Thromboembolism (del registro, en inglés).
- Fase
- no aplica
- Estado
- Interrumpido
- Participantes
- 21.000
- Centros
- 1
- Fin del objetivo primario
- dic 2023
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en abr 2023.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor's decision. Termination decision unrelated to safety profile.».
Qué mide
Change in the incidence of symptomatic VTE, from index date to Day 90 (Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroIn individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs) focusing specifically on this population. Evidence suggests that in obese participants, both higher dosing and duration of VTE prophylaxis with Low Molecular Weight Heparins (LMWH) may be required to achieve a therapeutic effect similar to non-obese participants. This non-interventional study utilizes data already collected from a usual clinical practice setting in the Optum US clinical database, representing obese participants hospitalized with an acute medical condition or undergoing surgery receiving enoxaparin prophylaxis. Its aim is to compare the impact of the following enoxaparin prophylaxis strategies on the incidence of symptomatic VTE and major bleeding in the overall study population and prespecified subgroups: * High versus conventional dose * Extended versus conventional duration * Combined High-Dose and Extended-Duration versus Conventional-Dose and Conventional-Duration. The first date of enoxaparin prophylaxis will be the index date.
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Ficha completa en ClinicalTrials.gov (NCT05819125), actualizada en oct 2024.