Conditions: Pulmonary Embolism Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism
Keywords: deep vein thrombosis pulmonary embolism long-term prevention of recurrent symptomatic VTE
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3365
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

Detailed description:

Arms:
arm 1: Rivaroxaban 10 mg once daily for 12 months arm 2: Rivaroxaban 20 mg once daily for 12 months arm 3: ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months

Interventions: intervention 1: BAY 59-7939 intervention 2: BAY 59-7939 intervention 3: ASA
Intervention descriptions: intervention 1: 10 mg tablet once daily for 12 months intervention 2: 20 mg tablet once daily for 12 months intervention 3: 100 mg tablet once daily for 12 months

Protocol document: