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DOJ closes investigation into clinical trial for ticagrelor
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The US Department of Justice has closed its investigation into the PLATO trial of ticagrelor, according to a press release from AstraZeneca.
PLATO included more than 18,000 patients with ACS across 43 countries and compared ticagrelor (Brilinta, AstraZeneca) with clopidogrel (Plavix, Sanofi Aventis/Bristol-Myers Squibb) when given in combination with aspirin and other standard treatment. According to the company, the DOJ does not intend to pursue further action.
On Oct. 21, 2013, a demand for civil investigation was presented to AstraZeneca by the DOJ, which sought information and documents related to the trial. This followed commentary critical of the study published in the International Journal of Cardiology, titled “Inactivations, deletions, non-adjudications and downgrades of clinical endpoints on ticagrelor: Serious concerns over the reliability of the PLATO trial.” The paper reviewed the FDA report, and researchers wrote that 46% of incidences of the primary endpoint that favored ticagrelor occurred in either Hungary or Poland, and also noted that the study was “easy to unblind,” with at least 452 participants unblinded, among other criticisms.
Since the announcement, members of the PLATO executive committee have commented on the DOJ’s decision to drop the investigation.
One of the study co-chairmen, Lars Wallentin, MD, PhD, senior professor of cardiology at Uppsala Clinical Research Center, Sweden, wrote in a statement, “Over the past years the academic leaders of the trial have repeatedly refuted allegations on the conduct and analyses of the PLATO trial. We therefore welcome the news that the US Department of Justice has closed its investigation of the PLATO trial and will take no further action.”
Robert A. Harrington
Another study co-chairman, Robert A. Harrington, MD, professor of medicine and chairman of the department of medicine at Stanford Medical Center, wrote, “This decision should remove any remaining doubts about the reliability of the trial results, and thereby support the implementation of the tested new treatment, not least in the United States.”
Ticagrelor has been studied in many other trials. Cardiology Today will cover results of the anticipated ATLANTIC trial, to be presented at the European Society of Cardiology Congress 2014 in Barcelona, Spain.
The drug was approved by the FDA in July 2011 with a black-box warning about the risk for increased bleeding.
No information from the DOJ was available at the time of publication.