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Video: Phase III Head to Head Trial Showed Ticagrelor Reduced Cardiovascular Death and Heart Attacks Over Clopidogrel in Acute Coronary Syndromes Patients
Date:8/29/2009

e composite of myocardial infarction, stroke, and all-cause mortality. Among patients who received a stent during the study, a 33% reduction in risk of definite stent thrombosis was achieved with ticagrelor.

"The goal of new antiplatelet therapies is to improve the efficacy for patients without increasing the associated risks of treatment such as bleeding. Ticagrelor achieved a significant reduction in CV mortality in ACS patients versus clopidogrel and importantly without an increase in major bleeding," commented Professor Lars Wallentin, co-chair of the PLATO Executive Committee, Uppsala Clinical Research Centre.

AstraZeneca Executive Vice-President Development, Anders Ekblom said, "The PLATO study was designed to reflect how patients with ACS are currently managed in clinical practice, by including patients who underwent invasive procedures and those who were managed with medication only. The PLATO data suggest ticagrelor could be a valuable new option for a broad range of acute coronary syndromes patients. We look forward to filing BRILINTA with regulatory authorities in the fourth quarter."

The PLATO study confirmed the clinical safety profile of previous ticagrelor studies which showed no difference in major bleeding compared to clopidogrel. When PLATO minor bleeding was added to the major bleeding results, ticagrelor showed an increase versus clopidogrel (16.1% vs. 14.6%, p=0.008). There was also an increase in non-procedural related bleeding with ticagrelor. Within the patient subgroups of gender, weight, history of stroke/TIA, ticagrelor showed no increase in the incidence of major bleeding versus clopidogrel.

Consistent with phase II data, ventricular pauses (slowing of heart rhythms) occurred more often with ticagrelor but without associated symptoms or clinical consequences for the patient. Dyspnoea was reported more frequently by patients on ticagrelor (13.8% vs. 7.8%, p < 0.
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SOURCE AstraZeneca
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