Concerns Arise Over Ticagrelor Platelet Studies
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New inquiry reveals potential inaccuracies in key studies supporting the drug’s approval.
By Alice Thompson | WASHINGTON, D.C. – 2025/06/23 10:10:06
A new investigation into the drug ticagrelor, used to prevent blood clots, has revealed potential issues with the platelet studies that supported its approval by the FDA. This follows a previous investigation by The BMJ that uncovered data integrity problems in the original clinical trial (PLATO) used for ticagrelor’s approval.
Ticagrelor, known as Brilinta in the US and Brilique in Europe, has been widely prescribed for over a decade to patients experiencing acute coronary syndrome, a condition involving reduced blood flow to the heart.
The latest investigation focuses on two key platelet studies cited by AstraZeneca as evidence of ticagrelor’s effectiveness in treating acute coronary syndrome. The findings suggest that the “primary endpoint” results from these trials were inaccurately reported in *Circulation*, a leading cardiology journal. Moreover, over 60 out of 282 readings from platelet machines used in the trials were absent from the US Food and Drug Governance (FDA) datasets.
The investigation also revealed that an active trial investigator was not credited as a study author. Another author told The BMJ he had no involvement in the trial. Most investigators,including the principal investigator,were either unreachable or declined to comment.
Expert Concerns and lack of Response
Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor’s most renowned critic, told The BMJ that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.”
“It’s been obvious for years that there is something wrong with the data.”
Neither *Circulation* nor AstraZeneca have responded to requests for comment regarding these findings.
Serebruany added: “It’s been obvious for years that there is something wrong with the data. That the FDA’s leadership coudl look past all these problems — on top of the many problems their own reviewers identified and are now being discovered by The BMJ — is unconscionable. We all need to know how and why that happened.”
