Clinical Trials

Date: 2016-03-23

Type of information: Results

phase: 3

Announcement: results

Company: AstraZeneca (UK)

Product: Brilinta® (ticagrelor)

Action mechanism: platelet aggregation inhibitor. Brilinta® (ticagrelor) is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). It works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with acute coronary syndrome (ACS).

Disease: prevention of major vascular events in patients with an acute ischaemic strok

Therapeutic area: Cardiovascular diseases

Country: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Republic of Korea, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, USA, Vietnam

Trial details: The SOCRATES study is part of AstraZeneca’s PARTHENON programme. The trial evaluated the efficacy and safety of 90-day treatment with Brilinta/Brilique versus aspirin for the prevention of major vascular events in patients > 40 years of age with an acute ischaemic stroke (National Institutes of Health Stroke Scale (NIHSS) < 5) or TIA (ABCD² score ?4). Patients randomised into the trial needed to have symptom onset within 24 hours. (NCT01994720)

Latest news:  

• • On March 23, 2016, AstraZeneca announced results of the SOCRATES trial, assessing the efficacy of Brilinta®/Brilique® (ticagrelor) 90mg tablets twice daily, when compared to aspirin 100mg once daily in patients with acute ischaemic stroke or transient ischaemic attack. The primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction and death was not met. Fewer events were observed on Brilinta® versus the comparator in the overall trial population but the trend did not reach statistical significance. Based on preliminary analyses, safety data is consistent with the known safety profile of Brilinta®. In the second half of 2016, data are expected from the ongoing EUCLID trial in peripheral arterial disease (PAD). EUCLID is the fourth trial to read-out from the PARTHENON programme, assessing the potential of Brilinta® in additional high-risk patient populations.

Is general: Yes