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Ticagrelor (Brilinta) Flops in Key Stroke Trial
AstraZeneca has announced the results from the pivotal SOCRATES trial, which assessed the efficacy of ticagrelor (Brilinta) 90 mg twice daily compared with aspirin 100 mg once daily in patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA). The primary efficacy endpoint of the time to the first occurrence of any event from the composite of stroke (ischemic or hemorrhagic), myocardial infarction (MI), and death was not met. Fewer vascular events were observed in the ticagrelor arm compared with the aspirin arm in the overall trial population, but the trend did not reach statistical significance.
The SOCRATES (Acute Stroke Or Transient IsChemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES) trial evaluated the efficacy and safety of 90-day treatment with ticagrelor compared with that of aspirin for the prevention of major vascular events in patients 40 years of age or older with AIS (National Institutes of Health Stroke Scale score of 5 or less) or TIA (an ABCD2 score of 4 or more). Patients enrolled into the trial needed to have symptom onset within 24 hours.
Ticagrelor is a direct-acting platelet P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic cardiovascular (CV) events, such as heart attack or CV death, in patients with acute coronary syndrome (ACS).
Ticagrelor 90 mg is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina, non–ST-elevation MI [NSTEMI], or ST-elevation MI [STEMI]). Ticagrelor 60 mg is indicated for the treatment of patients who have experienced a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment with ticagrelor 60 mg may be started as continuation therapy after an initial one-year treatment with ticagrelor 90 mg and aspirin or another dual antiplatelet therapy.
Ticagrelor has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared with clopidogrel. The difference between treatments was driven by CV death and MI, with no difference in stroke. Ticagrelor also reduced the rate of stent thrombosis in patients treated with percutaneous coronary intervention.
Source: AstraZeneca; March 23, 2016.