US DoJ closes investigation into AstraZeneca’s PLATO trial for Brilinta

Anglo-Swedish drug major AstraZeneca (LSE: AZN) has received confirmation from the US Department of Justice that it is closing its investigation into PLATO, a clinical trial with cardiovascular drug Brilinta (ticagrelor). The government is not planning any further action.

Last year, AstraZeneca said it was cooperating with a civil investigative demand from the US DoJ, Civil Division seeking documents and information regarding PLATO. PLATO was a large head-to-head patient outcomes study of Brilinta versus clopidogrel, both given in combination with aspirin and other standard therapy. The trial was designed to establish whether Brilinta plus aspirin could achieve a clinically meaningful reduction in cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and beyond that afforded by clopidogrel plus aspirin. Patients were treated for at least 6 months and up to 12 months.