SOCRATES trial results for Brilinta/Brilique presented at European Stroke Organisation Conference

Consistent safety profile; Missed primary efficacy endpoint

10 May 2016

AstraZeneca today 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 (TIA). The primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction (MI, also known as heart attack) and death was not met. The data were presented on 10^th May during a late-breaker session at the 2^nd European Stroke Organisation Conference (ESOC) in Barcelona and published in the New England Journal of Medicine.  

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Although the overall results showed that ticagrelor was not superior to aspirin in this patient population, we are encouraged that the safety profile was consistent with the known safety profile for ticagrelor and will continue to evaluate the full data set.”

During 90-day follow-up, a primary endpoint occurred in 442 (6.7%) patients treated with ticagrelor vs 497 (7.5%) treated with aspirin (Hazard Ratio (HR) 0.89, 95% CI 0.78-1.01, p=0.07). Ischaemic stroke – the secondary endpoint - occurred in 385 (5.8%) patients of the ticagrelor group and 441 (6.7%) of the aspirin group (HR 0.87, 95% CI 0.76-1.00, nominal p=0.046).

Major bleeding - the primary safety outcome - occurred in 31 patients (0.5%) and 38 patients (0.6%) treated with ticagrelor and aspirin respectively (HR 0.83, 95% CI 0.52-1.34). Intracranial haemorrhage occurred in 12 patients (0.2%) in the ticagrelor group vs 18 (0.3%) in the aspirin group. Fatal bleeding occurred in 9 patients (0.1%) in the ticagrelor group and 4 (0.1%) in the aspirin group. There were no significant differences in the other major safety outcomes.

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/Brilique in high-risk patient populations.

Brilinta/Brilique is not approved for secondary prevention in stroke or PAD.

NOTES TO EDITORS

About Stroke
Stroke is the second leading cause of death worldwide, with 16.9 million first strokes and 5.9 million stroke-related deaths in 2010. Patients who experience an acute ischemic stroke or TIA are at high risk of developing subsequent ischemic events, with particularly high risks of stroke in the first 90-days after the index event.

About SOCRATES
SOCRATES (Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES) is an event-driven global clinical trial involving patients in 33 countries. SOCRATES assessed the efficacy of Brilinta/Brilique compared to acetylsalicylic acid (ASA or aspirin) in reducing atherothrombotic events (a composite of stroke, myocardial infarction and death) in patients with acute ischaemic stroke NIHSS (≤ 5) and TIA (ABCD² score ≥4).

SOCRATES is one of the largest international randomised controlled trials to enrol both stroke and TIA patients within 24 hours of the primary event occurring.

About the PARTHENON programme
The SOCRATES trial is part of PARTHENON, the largest ever AstraZeneca CV outcomes programme, involving nearly 80,000 patients at high risk of CV events (MI, stroke and/or CV death) due to their underlying disease. Through the PARTHENON programme, AstraZeneca aims to address unmet patient needs by enhancing scientific understanding of the potential role of Brilinta/Brilique in the treatment of atherothrombotic conditions. It includes five key studies covering broad patient populations across varying timescales. The trials encompass a wide range of CV disorders, including coronary artery disease (PEGASUS-TIMI 54), peripheral arterial disease (EUCLID) and patients with type-2 diabetes at high risk of CV events (THEMIS).

About Brilinta/Brilique
Brilinta/Brilique is a direct-acting P2Y₁₂ receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilinta/Brilique works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV (cardiovascular) events, such as heart attack or CV death, in patients with ACS.

Brilinta/Brilique 90mg is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI)). Brilinta/Brilique 60mg is indicated for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment with Brilinta/Brilique 60mg may be started as continuation therapy after an initial one-year treatment with Brilinta/Brilique 90mg and aspirin or other dual anti-platelet therapy.

Brilinta/Brilique has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention, it also reduces the rate of stent thrombosis.

Brilinta and Brilique are registered trademarks of the AstraZeneca group.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal