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Credit: AstraZeneca
The US Department of Justice (DOJ) is closing its investigation of PLATO, a clinical trial of the antiplatelet agent ticagrelor (Brilinta), according to the drug’s developer, AstraZeneca.
The company also said the government is not planning any further action.
The DOJ began its investigation in October 2013, issuing a civil investigative demand requiring AstraZeneca to provide the department with documents and information related to the PLATO trial.
The trial compared ticagrelor to the antiplatelet agent clopidogrel in 18,624 patients with acute coronary syndromes (ACS), with or without ST-segment elevation.
The results suggested that ticagrelor significantly reduced the rate of myocardial infarction and death from any cause, although it did not decrease the risk of stroke. Ticagrelor did not increase the rate of overall bleeding, but it did increase the rate of bleeding not related to procedures.
These results led to ticagrelor’s approval in the US and more than 100 other countries. But members of the medical community questioned PLATO’s results, with some even suggesting the possibility of trial misconduct.
So the DOJ launched its investigation. The details of the inquiry are unclear, but AstraZeneca said it “focused on questions that have been raised previously in public about the trial.”
Many of those questions have been raised in the International Journal of Cardiology, in articles by Victor Serebruany, MD, PhD, of HeartDrug Research Laboratories in Towson, Maryland, and James DiNicolantonio, PharmD, of Wegmans Pharmacy in Ithaca, New York.
In the years since PLATO’s results were first published, Drs DiNicolantonio and Serebruany have pointed out differences between trial data published in the NEJM paper and FDA reviews of the data, noted the geographic discrepancies in results observed with ticagrelor, and raised questions about site monitoring, blinding practices, and patient deaths, among other issues.
PLATO investigators addressed these questions and allegations in an article of their own, which appeared in the International Journal of Cardiology in December 2013. The overall message was that PLATO’s results are valid.
“We have always had absolute confidence in the integrity of the PLATO trial, and we are proud of the important benefit [ticagrelor] offers to patients around the world suffering from acute coronary syndrome,” said Pascal Soriot, AstraZeneca’s Chief Executive Officer.
As for the future of ticagrelor, AstraZeneca recently announced the start of the SOCRATES trial, a study of the drug for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with type 2 diabetes and coronary atherosclerosis.
These studies form part of PARTHENON, a trial program involving more than 80,000 patients worldwide. The program also includes 2 trials that have recently completed recruitment—EUCLID, a study of patients with peripheral artery disease and PEGASUS, a study of ticagrelor for secondary prevention in patients with previous myocardial infarction.
AstraZeneca expects headline results from PEGASUS to be available in the first quarter of 2015. 
Credit: AstraZeneca
The US Department of Justice (DOJ) is closing its investigation of PLATO, a clinical trial of the antiplatelet agent ticagrelor (Brilinta), according to the drug’s developer, AstraZeneca.
The company also said the government is not planning any further action.
The DOJ began its investigation in October 2013, issuing a civil investigative demand requiring AstraZeneca to provide the department with documents and information related to the PLATO trial.
The trial compared ticagrelor to the antiplatelet agent clopidogrel in 18,624 patients with acute coronary syndromes (ACS), with or without ST-segment elevation.
The results suggested that ticagrelor significantly reduced the rate of myocardial infarction and death from any cause, although it did not decrease the risk of stroke. Ticagrelor did not increase the rate of overall bleeding, but it did increase the rate of bleeding not related to procedures.
These results led to ticagrelor’s approval in the US and more than 100 other countries. But members of the medical community questioned PLATO’s results, with some even suggesting the possibility of trial misconduct.
So the DOJ launched its investigation. The details of the inquiry are unclear, but AstraZeneca said it “focused on questions that have been raised previously in public about the trial.”
Many of those questions have been raised in the International Journal of Cardiology, in articles by Victor Serebruany, MD, PhD, of HeartDrug Research Laboratories in Towson, Maryland, and James DiNicolantonio, PharmD, of Wegmans Pharmacy in Ithaca, New York.
In the years since PLATO’s results were first published, Drs DiNicolantonio and Serebruany have pointed out differences between trial data published in the NEJM paper and FDA reviews of the data, noted the geographic discrepancies in results observed with ticagrelor, and raised questions about site monitoring, blinding practices, and patient deaths, among other issues.
PLATO investigators addressed these questions and allegations in an article of their own, which appeared in the International Journal of Cardiology in December 2013. The overall message was that PLATO’s results are valid.
“We have always had absolute confidence in the integrity of the PLATO trial, and we are proud of the important benefit [ticagrelor] offers to patients around the world suffering from acute coronary syndrome,” said Pascal Soriot, AstraZeneca’s Chief Executive Officer.
As for the future of ticagrelor, AstraZeneca recently announced the start of the SOCRATES trial, a study of the drug for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with type 2 diabetes and coronary atherosclerosis.
These studies form part of PARTHENON, a trial program involving more than 80,000 patients worldwide. The program also includes 2 trials that have recently completed recruitment—EUCLID, a study of patients with peripheral artery disease and PEGASUS, a study of ticagrelor for secondary prevention in patients with previous myocardial infarction.
AstraZeneca expects headline results from PEGASUS to be available in the first quarter of 2015.
Credit: AstraZeneca
The US Department of Justice (DOJ) is closing its investigation of PLATO, a clinical trial of the antiplatelet agent ticagrelor (Brilinta), according to the drug’s developer, AstraZeneca.
The company also said the government is not planning any further action.
The DOJ began its investigation in October 2013, issuing a civil investigative demand requiring AstraZeneca to provide the department with documents and information related to the PLATO trial.
The trial compared ticagrelor to the antiplatelet agent clopidogrel in 18,624 patients with acute coronary syndromes (ACS), with or without ST-segment elevation.
The results suggested that ticagrelor significantly reduced the rate of myocardial infarction and death from any cause, although it did not decrease the risk of stroke. Ticagrelor did not increase the rate of overall bleeding, but it did increase the rate of bleeding not related to procedures.
These results led to ticagrelor’s approval in the US and more than 100 other countries. But members of the medical community questioned PLATO’s results, with some even suggesting the possibility of trial misconduct.
So the DOJ launched its investigation. The details of the inquiry are unclear, but AstraZeneca said it “focused on questions that have been raised previously in public about the trial.”
Many of those questions have been raised in the International Journal of Cardiology, in articles by Victor Serebruany, MD, PhD, of HeartDrug Research Laboratories in Towson, Maryland, and James DiNicolantonio, PharmD, of Wegmans Pharmacy in Ithaca, New York.
In the years since PLATO’s results were first published, Drs DiNicolantonio and Serebruany have pointed out differences between trial data published in the NEJM paper and FDA reviews of the data, noted the geographic discrepancies in results observed with ticagrelor, and raised questions about site monitoring, blinding practices, and patient deaths, among other issues.
PLATO investigators addressed these questions and allegations in an article of their own, which appeared in the International Journal of Cardiology in December 2013. The overall message was that PLATO’s results are valid.
“We have always had absolute confidence in the integrity of the PLATO trial, and we are proud of the important benefit [ticagrelor] offers to patients around the world suffering from acute coronary syndrome,” said Pascal Soriot, AstraZeneca’s Chief Executive Officer.
As for the future of ticagrelor, AstraZeneca recently announced the start of the SOCRATES trial, a study of the drug for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with type 2 diabetes and coronary atherosclerosis.
These studies form part of PARTHENON, a trial program involving more than 80,000 patients worldwide. The program also includes 2 trials that have recently completed recruitment—EUCLID, a study of patients with peripheral artery disease and PEGASUS, a study of ticagrelor for secondary prevention in patients with previous myocardial infarction.
AstraZeneca expects headline results from PEGASUS to be available in the first quarter of 2015.