Conditions: Venous Thromboembolism
Keywords: Acute medical illnesses with increased risk for VTE. Deep vein thrombosis (DVT) Pulmonary embolism (PE), Venous Thromboembolic disease (VTE), Medical illness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8101
Healthy volunteers: no

Brief summary:
This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Detailed description:
The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Arms:
arm 1: Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days arm 2: Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days

Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Rivaroxaban placebo intervention 4: Enoxaparin placebo
Intervention descriptions: intervention 1: Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days intervention 2: Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days intervention 3: Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days intervention 4: Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Protocol document: