None listed
Conditions
Brief summary
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic PE with or without symptomatic DVT (Einstein-PE). (11702b) This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study). (11899)
Interventions
Patients allocated to the rivaroxaban arm of the prevention trial (Bay 59-7939 / 11702) will receive rivaroxaban 15 mg twice daily orally for a total of 3 weeks and thereafter patients will receive rivaroxaban 20 mg once daily.
Patients from both the rivaroxaban and enoxaparin treatment arms will be treated for 3, 6 or 12 months depending on the risk profile of the patients and the preference of the investigator.
Patients continuing in the extension study (Bay 59-7939 / 11899) will receive ri
Patients allocated to the rivaroxaban arm of the prevention trial (Bay 59-7939 / 11702) will receive rivaroxaban 15 mg twice daily orally for a total of 3 weeks and thereafter patients will receive rivaroxaban 20 mg once daily. Patients from both the rivaroxaban and enoxaparin treatment arms will be treated for 3, 6 or 12 months depending on the risk profile of the patients and the preference of the investigator. Patients continuing in the extension study (Bay 59-7939 / 11899) will receive rivaroxaban or matching placebo 20 mg orally once daily. Treatment duration will be 6 or 12 months and should be indicated prior to randomisation.
Sponsors
Bayer Australia Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for Bay 59-7939 / 11702. Confirmed acute symptomatic proximal deep vein thrombosis or confirmed acute symptomatic pulmonary embolism. Active bleeding.Inclusion criteria for Bay 59-7939 / 11899.Confirmed acute symptomatic deep vein thrombosis or pulmonary embolism who have been treated for 6 or 12 months with vitamin K antagonist.
Exclusion criteria
Exclusion criteria for 11702Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Other indication for VKA other than DVT and/or PE. More than 36 hours pre-randomisation treatment with therapeutic dosages of low molecular weight heparin / fondaparinux or more than a single dose of VKA prior to randomisation.Significant renal or liver disease. Exclusion criteria for 11899Other indication for VKA other than DVT and/or PE.Significant renal or liver disease.Systolic blood pressure greater than 180 mmHg or diastolic greater than 110 mmHgActive bleeding. Bacterial endocarditis.Active bleeding or high risk for bleeding.Life expectancy less than 3 months.
Outcome results
None listed