Acute coronary syndromes
Conditions
Brief summary
Assessed between 1 and 12 months after PCI Effectiveness: Clinically relevant bleeding (BARC 2, 3 and 5 ). Powered for superiority, Assessed between 1 and 12 months after PCI Safety: Composite major adverse cardiovascular or cerebrovascular events (MACCE) (a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization). Powered for non-inferiority.
Detailed description
Individual components of the primary end point comprised the secondary end points, Stent thrombosis rate according to the Academic Research Consortium-2 definition, Major bleeding (BARC type 2, 3 and 5), Health-related quality of life, Angina status based on the Canadian Cardiovascular Society classification system
Interventions
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessed between 1 and 12 months after PCI Effectiveness: Clinically relevant bleeding (BARC 2, 3 and 5 ). Powered for superiority, Assessed between 1 and 12 months after PCI Safety: Composite major adverse cardiovascular or cerebrovascular events (MACCE) (a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization). Powered for non-inferiority. | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of the primary end point comprised the secondary end points, Stent thrombosis rate according to the Academic Research Consortium-2 definition, Major bleeding (BARC type 2, 3 and 5), Health-related quality of life, Angina status based on the Canadian Cardiovascular Society classification system | — |
Countries
Denmark
Outcome results
None listed