Atrial fibrillation Acute coronary syndrome Chronic coronary syndrome
Conditions
Brief summary
The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI., The co-primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.
Detailed description
Key secondary endpoints include the primary safety and efficacy outcomes at 6 months after successful PCI., Exploratory analysis of the individual components of the main secondary endpoint, Net clinical benefit comprising of major bleeding, myocardial infarction, stroke, systemic embolism, all cause death, and stent thrombosis, Quality of life
Interventions
DRUGTICAGRELOR MICRO LABS 90 mg
DRUGcomprimé pelliculé
DRUGPrasugrel 5 mg film-coated tablets
Sponsors
St Antonius Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI., The co-primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints include the primary safety and efficacy outcomes at 6 months after successful PCI., Exploratory analysis of the individual components of the main secondary endpoint, Net clinical benefit comprising of major bleeding, myocardial infarction, stroke, systemic embolism, all cause death, and stent thrombosis, Quality of life | — |
Countries
Belgium, Denmark, Italy, Netherlands
Outcome results
None listed