Conditions: Venous Thromboembolism
Keywords: Prevention of venous thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3148
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Detailed description:

Arms:
arm 1: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening. arm 2: Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Placebo: tablet of Rivaroxaban intervention 4: Placebo: syringes of Enoxaparin
Intervention descriptions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening. intervention 2: Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening. intervention 3: Placebo tablet of rivaroxaban administered once daily in the evening. intervention 4: Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Protocol document: