Open AccessVerifying Death Reports in the Platelet Inhibition and Patient Outcomes (PLATO) Trial
Author(s) -
Victor L. Serebruany,
JeanFrançois Tanguay,
Mario Alberto Benavides,
Héctor A. Cabrera-Fuentes,
Wolfgang G. Eisert,
Moo Hyun Kim,
Junghan Yoon,
Cheol-Whan Lee,
Kiyuk Jang,
James Swan,
Thomas A. Marciniak
Publication year - 2020
Publication title -
american journal of therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.349
H-Index - 62
eISSN - 1536-3686
pISSN - 1075-2765
DOI - 10.1097/mjt.0000000000001286
Subject(s) - ticagrelor , medicine , clopidogrel , clinical endpoint , cause of death , clinical trial , emergency medicine , aspirin , disease
Excess vascular deaths in the PLATO trial comparing ticagrelor to clopidogrel have been repeatedly challenged by the Food and Drug Administration (FDA) reviewers and academia. Based on the Freedom of Information Act, BuzzFeed won a court order and shared with us the complete list of reported deaths for the ticagrelor FDA New Drug Application (NDA) 22-433. This dataset was matched against local patient-level records from PLATO sites monitored by the sponsor.