Evidence mapPaperPMID 40351676Full record

ArticleReviews in cardiovascular medicine2025

Impact of Central Event Adjudication on the PLATO Trial Results.

Victor L Serebruany, Wendy Ziai, Hector A Cabrera-Fuentes, Brendon Pokov, Isabella Hwang, Thomas Marciniak

Abstract read
In one paragraph

Article in Reviews in cardiovascular medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Victor L SerebruanyDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.ORCID https://orcid.org/0000-0002-6597-5445
Wendy ZiaiDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.ORCID https://orcid.org/0000-0003-4548-7353
Hector A Cabrera-FuentesR&D Group, Vice Presidency for Scientific Research and Innovation, Imam Abdulrahman bin Faisal University (IAU), 31441 Dammam, Saudi Arabia.ORCID https://orcid.org/0000-0002-8502-7098
Brendon PokovHeartDrug Research LLC, West Friendship, MD 21294, USA.
Isabella HwangHeartDrug Research LLC, West Friendship, MD 21294, USA.
Thomas MarciniakPhysician, retired from FDA, Alexandria, VA 22314, USA.ORCID https://orcid.org/0000-0003-1801-1624

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This study aimed to determine the impact of central adjudication of site-reported events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in addition to aspirin within the frame of indication-seeking The PLATelet Inhibition and Clinical Outcomes (PLATO) trial. Adjudication in randomized outcome-driven trials is supposed to maintain integrity by applying uniform rules for the quality assessment of clinical events. Some preliminary data suggest an imbalance between central and site diagnoses in PLATO. We gained access to the Food and Drug Administration (FDA)-issued adjudication dataset and analyzed the evidence. Methods: Death, myocardial infarction (MI), stroke/ transient ischemic attack (TIA), bleeding, arterial thrombotic events, and cardiac ischemic events underwent central adjudication. We assessed geography, timing, impact of disagreements, and primary endpoint composition. Results: Among 18,624 trial enrollees, 10,704 central adjudications occurred across 7171 patients in 43 countries. There were 938 deaths, 2751 cases of MI, 359 strokes/TIAs, 2680 cardiac events, 130 thrombotic events, and 3782 bleeding events. The match occurred for 5451 events, while mismatches favoring clopidogrel (n = 2535) or ticagrelor (n = 2706) ( Conclusion: 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.

Indexed as

bleedingclinical trialdeathevent adjudicationmyocardial infarctionprimary endpointstroke

Identifiers

PMID40351676
PMCPMC12059727

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.