Prevention of Symptomatic Venous Thromboembolism by Low Molecular Weight Heparin in Hospitalized Medical Patients aged 70 years and older : a Randomized Placebo-Controlled Study

INTERVENTION: Trade Name: Lovenox 4000 UI anti‐Xa/0,4 ml Product Name: Lovenox Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Therapeutic area: Not possible to specify Venous Thromboembolism ; MedDRA version: 18.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865 PRIMARY OUTCOME: Main Objective: To demonstrate the efficacy on the risk of symptomatic VTE at one month of low molecular weight heparin enoxaparin 40 mg once daily subcutaneously for 10 ± 4 days as compared with placebo in patients aged 75 years or more who have been hospitalized for an acute medical illness. Primary end point(s): The primary outcome is the occurrence of any of the following events through the day 30 visit : symptomatic confirmed deep venous thrombosis (DVT), symptomatic confirmed pulmonary embolism (PE), or fatal PE Secondary Objective: • To evaluate whether the use of prophylactic dose of low molecular weight heparin reduces the risk of symptomatic VTE at 3 months in hospitalized elderly medical patients; • To assess the risk of bleeding associated with the use of prophylactic low molecular weight heparin at 1month and at 3 months; • To assess the net clinical benefit (symptomatic VTE and major bleeding events) associated with the use of low molecular weight heparin at 1 month and at 3 months; • To assess the impact of low molecular weight heparin on atherothrombotic cardiovascular events at 1 month and 3 months; • To assess the impact of low molecular weight heparin on mortality from any cause at 1 month and at 3 months; • To assess the risk of cardiovascular death at 1 month and at 3 months ; Timepoint(s) of evaluation of this end point: day 30 visit SECONDARY OUTCOME: Secondary end point(s): The secondary outcomes is the occurrence of any of the following events ; • Symptomatic confirmed VTE (DVT or PE) or fatal PE through the day 90 visit ; • Major bleeding as defined by the criteria of the International Society of Thrombosis and Haemostasis through the day 30 and the day 90 visit ; • Clinically relevant non major bleeding and any bleeding through the day 30 and the day 90 visit ; • Atherothrombotic cardiovascular events through the day 30 and the day 90 visit ; • Cardiovascular death through the day 30 and the day 90 visit ; • Death from any cause through the day 30 and the day 90 visit ; ; All events are adjudicated by the CEC ; Timepoint(s) of evaluation of this end point: day 30 and the day 90 visit ; INCLUSION CRITERIA: • Patient aged 75 years or older • Admitted to hospital for an acute medical illness • Anticipated duration of hospitalization of at least 4 days • Life expectancy of at least 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5030