Impact of patient selection in clinical trials: application of ROCKET AF and ARISTOTLE criteria in GARFIELD-AF.

Jelle C L HimmelreichSaverio VirdoneJohn CammKaren PieperRalf E HarskampAli OtoBarry F JacobsonJ P S SawhneyToon Wei LimHarry GibbsShinya GotoSylvia HaasKeith A A FoxPetr JanskyFreek VerheugtAjay K Kakkarnull null

Published in: Open heart (2024)

Apixaban and rivaroxaban showed similar results versus VKA in high-risk patients selected according to ROCKET AF criteria, whereas differences emerged when selecting for the more inclusive ARISTOTLE criteria. Our results highlight the importance of trial selection criteria in interpreting trial results and underline the problems faced in comparing treatments across rather than within clinical trials.

Keyphrases

clinical trial
atrial fibrillation
phase ii
phase iii
end stage renal disease
study protocol
venous thromboembolism
ejection fraction
newly diagnosed
chronic kidney disease
mental health
case report
pulmonary embolism
prognostic factors
randomized controlled trial
patient reported outcomes
double blind