Venous Thromboembolism Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization
Primary objective:
- To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd
for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment
with enoxaparin 40mg sc qd
Secondary objectives:
- To assess the reduction in mortality rate at the end of the double-blind treatment
period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to
the study, in patients on extended prophylaxis
- To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of
randomization to the study
- To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical
patients with prolonged immobilization. Safety evaluation includes:
- Major and minor hemorrhage
- Heparin induced thrombocytopenia
- Serious adverse events
- To assess differences in levels of health-care utilization and cost between patients
receiving extended VTE prophylaxis versus those receiving placebo.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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