MAGELLaN - Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin

Hospitalization for an acute medical illness is independently associated with
about an eightfold increased relative risk for VTE and accounts for almost one
quarter of all VTE events within the general population. Thus, the appropriate
prophylaxis of medical inpatients offers an important opportunity to
significantly reduce the burden of disease due to VTE. The American College of
Chest Physicians (ACCP) recommends either unfractionated heparin or LMWH in
acutely ill medical patients who have been admitted to the hospital with
congestive heart failure or severe respiratory disease or who are confined to
bed and have one or more additional risk factors, including active cancer,
previous VTE, sepsis, acute neurological disease or inflammatory bowel disease.
Potential disadvantage of treatment with LMWH is the (rare) chance of
heparin-induced trombopenia(HIT).

The objective of this study is to demonstrate (1) the superior efficacy of VTE
prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 ± 4 days
to SC enoxaparin 40 mg once daily (OD) administered for 10 ± 4 days in men and
women aged 40 years or above who have been hospitalized for a medical illness
and (2) the non-inferiority of VTE prophylaxis with oral rivaroxaban 10 mg once
daily administered for 10 ± 4 days to SC enoxaparin 40 mg once daily for
10 ± 4 days in the same patient population. The safety of rivaroxaban and
enoxaparin will be compared as well.

The study will be conducted in a prospective, randomized, double blind,
double-dummy, active comparator controlled, multi-center and multi-national
design.

Enoxaparin 40 mg SC once daily for 10 +/- 4 days or rivaroxaban 10 mg orally
(PO) once daily for 35 +/- 4 days

From each patient 6 bloodsamples will be drawn during the duration of the
study. In each patient an ultrasonogram will be performed on Day 10 +/- 4 days
and Day 35 +/- 4 days for the presence or absence of thrombi in the deep venous
system of the lower extremities.