Treatment with a Vitamin K Antagonist due to having a mechanical bileaflet aortic valve replacement.
Conditions
Brief summary
Thrombosis/thromboembolism (composite of ischemic stroke, systemic thromboembolism, valve thrombosis) and major bleeding.
Detailed description
All-cause mortality (selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline), All clinically important bleeding, Minor bleeding, All stroke, Ischemic stroke, Hemorrhagic stroke, Type 1, 2 or 3 myocardial infarction, Systemic thromboembolism, Valve thrombosis, Pulmonary embolism, Deep vein thrombosis, New renal replacement therapy, Time in therapeutic range, Proportion of patients with extreme INR values (>4)
Interventions
Sponsors
Hamilton Health Sciences Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombosis/thromboembolism (composite of ischemic stroke, systemic thromboembolism, valve thrombosis) and major bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality (selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline), All clinically important bleeding, Minor bleeding, All stroke, Ischemic stroke, Hemorrhagic stroke, Type 1, 2 or 3 myocardial infarction, Systemic thromboembolism, Valve thrombosis, Pulmonary embolism, Deep vein thrombosis, New renal replacement therapy, Time in therapeutic range, Proportion of patients with extreme INR values (>4) | — |
Countries
Belgium, Denmark, Germany, Italy, Netherlands, Spain
Outcome results
None listed