Isolated Subsegmental Pulmonary Embolism
Conditions
Brief summary
The primary outcome will be the proportion of recurrent, clinically symptomatic, objectively confirmed VTE within 90 days of randomization, defined as recurrent fatal or nonfatal pulmonary embolism (PE) or lower limb deep vein thrombosis (DVT; efficacy).
Detailed description
The secondary outcomes will be the proportion of clinically significant bleeding and all-cause mortality at 90 days of randomization (safety)., The ancillary outcomes will be health-related quality of life, functional status, and medical resource utilization at 90 days of randomization.
Interventions
DRUGPlacebo for BAY 597939
DRUGRivaroxaban Bayer
Sponsors
Insel Gruppe AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the proportion of recurrent, clinically symptomatic, objectively confirmed VTE within 90 days of randomization, defined as recurrent fatal or nonfatal pulmonary embolism (PE) or lower limb deep vein thrombosis (DVT; efficacy). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes will be the proportion of clinically significant bleeding and all-cause mortality at 90 days of randomization (safety)., The ancillary outcomes will be health-related quality of life, functional status, and medical resource utilization at 90 days of randomization. | — |
Countries
Belgium, France, Netherlands
Outcome results
None listed