Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights.
Josep Ramon MarsalIratxe Urreta-BarallobreMarimar Ubeda-CarrilloDimelza OsorioBlanca LumbrerasDavid LoraBorja M Fernández-FelixGerard OristrellEduard Ródenas-AlesinaLorena HerradorMónica BallesterosJavier ZamoraJose I PijoanAida RiberaIgnacio Ferreira-GonzálezPublished in: Trials (2022)
The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.
Keyphrases
- cardiovascular events
- coronary artery disease
- cardiovascular disease
- acute myocardial infarction
- study protocol
- phase iii
- clinical trial
- phase ii
- genetic diversity
- percutaneous coronary intervention
- randomized controlled trial
- open label
- emergency department
- adverse drug
- acute coronary syndrome
- atrial fibrillation