Ticagrelor Study Flaws | Heart Drug Concerns
- New concerns have surfaced regarding the multibillion-dollar drug ticagrelor, focusing on key platelet studies that supported its approval by the Food and Drug Administration.
- and Brilique in Europe, has been a recommended treatment for acute coronary syndrome, conditions involving reduced blood flow to the heart, for over a decade.
- A prior investigation highlighted data integrity issues in the pivotal PLATO clinical trial, which led to ticagrelor's global approval.The findings cast doubt on whether the drug is superior...
New revelations expose notable inaccuracies in critical studies that supported the FDA approval of ticagrelor, a widely prescribed heart drug. Our investigation reveals issues within the data, including inaccurately reported results and missing information from key clinical trials, raising major concerns about the drug’s efficacy. With generic versions of this primary_keyword expected soon, the integrity of the data supporting secondary_keyword prescriptions comes under scrutiny. news Directory 3 is tracking these developments closely, and sources say authorities may scrutinize the approval and current use of Ticagrelor. Discover what’s next …
Inaccuracies Uncovered in Key Studies of Heart Drug Ticagrelor
Updated June 20, 2025
New concerns have surfaced regarding the multibillion-dollar drug ticagrelor, focusing on key platelet studies that supported its approval by the Food and Drug Administration. This follows a previous investigation into the drug.
Ticagrelor, known as Brilinta in the U.S. and Brilique in Europe, has been a recommended treatment for acute coronary syndrome, conditions involving reduced blood flow to the heart, for over a decade.
A prior investigation highlighted data integrity issues in the pivotal PLATO clinical trial, which led to ticagrelor’s global approval.The findings cast doubt on whether the drug is superior to less expensive alternatives.
As generic versions of ticagrelor are expected to be released this year, an expanded investigation examined two platelet studies that AstraZeneca claimed validated ticagrelor’s effectiveness in treating acute coronary syndrome.
The investigation revealed that the primary endpoint results for both clinical trials were inaccurately reported in the journal Circulation. Moreover, over 60 of 282 readings from platelet machines used in the trials were absent from the FDA datasets.
An active trial investigator was not listed as a study author.One listed author stated they had no involvement in the trial.Moast investigators, including the principal investigator, could not be reached or declined to comment.
dr. victor Serebruany, an adjunct faculty member at Johns Hopkins University and a prominent critic of ticagrelor, said that the drug can cause important platelet rebound and inhibition, potentially leading to thrombosis or bleeding. Serebruany said that if physicians were aware of the issues in these trials,they might not have prescribed ticagrelor.
Neither circulation nor AstraZeneca responded to requests for comment.
Serebruany added that the data issues have been apparent for years. He questioned how the FDA leadership overlooked these problems, along with issues identified by their own reviewers.
What’s next
The investigation’s findings may prompt further scrutiny of ticagrelor’s approval and usage, especially as generic versions become available. The FDA may face pressure to address the concerns raised about the data and its review processes.