AF patients who have undergone successful PCI
Conditions
Brief summary
Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months, Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months
Detailed description
The individual components of each primary endpoints, The composite of death from cardiovascular causes, myocardial infarction, or stroke, The composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism, Death from cardiovascular or non-cardiovascular causes, The composite of stroke and non-CNS systemic embolism, Any stroke (including ischemic, hemorragic, and unknown types), Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack, The composite of definite or probable stent thrombosis, Definite stent thrombosis, Hospitalization, The composite of death or hospitalization, Any target lesion revascularization, Any target vessel revascularization, Any revascularization, All bleeding events, also adjudicated according to BARC, TIMI or GUSTO scales, Transfusion rates both in patients with and/or without clinically detected overt bleeding
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months, Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The individual components of each primary endpoints, The composite of death from cardiovascular causes, myocardial infarction, or stroke, The composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism, Death from cardiovascular or non-cardiovascular causes, The composite of stroke and non-CNS systemic embolism, Any stroke (including ischemic, hemorragic, and unknown types), Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack, The composite of definite or probable stent thrombosis, Definite stent thrombosis, Hospitalization, The composite of death or hospitalization, Any target lesion revascularization, Any target vessel revascularization, Any revascularization, All bleeding events, also adjudicated according to BARC, TIMI or GUSTO scales, Transfusion rates both in patients with and/or without clinically detected overt bleeding | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Spain