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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,726
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Buenos Aires, Argentina
Sanofi-Aventis
North Ryde, Australia
Sanofi-Aventis
Vienna, Austria
Sanofi-Aventis
Brussels, Belgium
Sanofi-Aventis
São Paulo, Brazil
Sanofi-Aventis
Laval, Canada
Sanofi-Aventis
Bogotá, Colombia
Sanofi-Aventis
Paris, France
Sanofi-Aventis
Berlin, Germany
...and 10 more locations
During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.
Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
Minor plus major hemorrhagic complications during Double-Blind Treatment.
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