Patients with atrial fibrillation requiring anticoagulation.
Conditions
Brief summary
Major bleeding at 30 days, defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more, or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood
Detailed description
Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days. This is intended to be confirmatory as high quality evidence has demonstrated DOACs to be superior to VKAs for thromboembolic protection., Major bleeding at 90 days; pleural effusion requiring drainage, pericardial effusion requiring drainage, systemic arterial embolism, ischemic stroke, deep vein thrombosis, pulmonary embolism, all-cause mortality, length of postoperative hospital stay at 30 and 90 days; all-cause mortality at 6 months., Minor bleeding, all bleeding, myocardial infarction, valve thrombosis, hemorrhagic stroke, all stroke, all arterial thrombosis/thromboembolism (ischemic stroke, systemic arterial embolism, myocardial infarction, valve thrombosis), quality of life measured by the EQ-5D-5L questionnaire, patient satisfaction with their anticoagulant treatment as assessed by the Perception of Anticoagulant Treatment Questionnaire (PACT-Q) and aggregate costs for both groups at 30 and 90 days.
Interventions
Sponsors
Hamilton Health Sciences Corporation, Hamilton Health Sciences Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major bleeding at 30 days, defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more, or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days. This is intended to be confirmatory as high quality evidence has demonstrated DOACs to be superior to VKAs for thromboembolic protection., Major bleeding at 90 days; pleural effusion requiring drainage, pericardial effusion requiring drainage, systemic arterial embolism, ischemic stroke, deep vein thrombosis, pulmonary embolism, all-cause mortality, length of postoperative hospital stay at 30 and 90 days; all-cause mortality at 6 months., Minor bleeding, all bleeding, myocardial infarction, valve thrombosis, hemorrhagic stroke, all stroke, all arterial thrombosis/thromboembolism (ischemic stroke, systemic arterial embolism, myocardial infarction, valve thrombosis), quality of life measured by the EQ-5D-5L questionnaire, patient satisfaction with their anticoagulant treatment as assessed by the Perception of Anticoagulant Treatment Questionnaire (PACT-Q) and aggregate costs for both groups a | — |
Countries
Germany
Outcome results
None listed