Impact of Central Event Adjudication on the PLATO Trial Results

Central adjudication in the PLATO trial was delayed and impacted the primary endpoint by inflating the ticagrelor benefit, resulting in drug approval. The regulatory authorities should consider independent audits when unblinding is suspected in the indication-seeking clinical trials.

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Publication Details

Journal
Reviews in Cardiovascular Medicine
Published
2025-04-27
DOI
https://doi.org/10.31083/rcm36733
Citations
2
Primary Topic
Antiplatelet Therapy and Cardiovascular Diseases
Type
article
Field-Weighted Citation Impact
2.78
Controls
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article

Impact of Central Event Adjudication on the PLATO Trial Results

Victor L. Serebruany, Wendy Ziai, Thomas A. Marciniak, Héctor A. Cabrera-Fuentes et al.
2 citations
Reviews in Cardiovascular Medicine
Antiplatelet Therapy and Cardiovascular Diseases
2.78
article

Impact of Central Event Adjudication on the PLATO Trial Results

Victor L. Serebruany, Wendy Ziai, Thomas A. Marciniak, Héctor A. Cabrera-Fuentes, Isabella Hwang, Brendon Pokov
article en
2 citations

Abstract

Central adjudication in the PLATO trial was delayed and impacted the primary endpoint by inflating the ticagrelor benefit, resulting in drug approval. The regulatory authorities should consider independent audits when unblinding is suspected in the indication-seeking clinical trials.

Reviews in Cardiovascular MedicineVol. 26(4)
Johns Hopkins University (US), Johns Hopkins Medicine (US), University of Maryland, College Park (US), Imam Abdulrahman Bin Faisal University (SA), Benito Juárez Autonomous University of Oaxaca (MX)
Openalex Percentile: Top 10%
Antiplatelet Therapy and Cardiovascular Diseases
2.78
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