Brilinta (Ticagrelor) in Combination with Aspirin Significantly Reduces Stroke and Death Risk Following Acute Ischemic Stroke or High-Risk TIA

AstraZeneca recently announced that the Phase III THALES trial, evaluating the cardiovascular outcomes of the anticoagulant Brilinta (ticagrelor), met its primary endpoint. The results showed that initiating treatment within 24 hours after an acute ischemic stroke or transient ischemic attack (TIA) reduced the composite risk of stroke and death with Brilinta plus aspirin compared to aspirin alone.

This study was a randomized, placebo-controlled, double-blind, international, multicenter, event-driven trial sponsored by AstraZeneca, involving more than 11,000 patients. The objective was to evaluate whether Brilinta in combination with aspirin was superior to aspirin monotherapy in preventing the composite endpoint of stroke and death among patients with mild acute ischemic stroke or high-risk transient ischemic attack (TIA).

In the study, these patients were randomized and treated for 30 days within 24 hours after the onset of symptoms of acute ischemic stroke or high-risk TIA. The experimental treatment consisted of a 180 mg loading dose of Brilinta administered as soon as possible on Day 1 following randomization, followed by 90 mg twice daily from Days 2 to 30, or matched placebo. All patients received open-label aspirin therapy, with 300–325 mg on Day 1 and 75–100 mg once daily from Days 2 to 30. The primary efficacy outcome was the time to the composite endpoint of stroke and death within 30 days of treatment. The primary safety outcome was the time to first occurrence of severe bleeding events as defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) criteria. Patients were followed for an additional 30 days in accordance with standard care.

High-level results from the study demonstrated that, compared with aspirin monotherapy, treatment with Brilinta 90 mg twice daily in combination with aspirin for 30 days resulted in a statistically and clinically significant reduction in the risk of the primary composite endpoint of stroke and death. The preliminary safety findings were consistent with the established safety profile of Brilinta, with an increased incidence of bleeding observed in the treatment group.

Stroke is the second leading cause of death globally, with 6.2 million deaths attributed to stroke in 2017, including 2.7 million deaths from ischemic stroke. Patients who experience an acute ischemic stroke or transient ischemic attack (TIA) are at high risk for secondary ischemic events, particularly within the first 30 days after the initial event, with the highest risk occurring within the first 24 hours.

To date, Brilinta has been approved in more than 110 countries for the treatment of acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events in patients at high risk of myocardial infarction.

In patients with acute coronary syndrome (ACS) or a history of myocardial infarction, Brilinta in combination with aspirin has been shown to significantly reduce the risk of major adverse cardiovascular events (myocardial infarction, stroke, or cardiovascular death). The regimen of Brilinta combined with aspirin is indicated for adult patients with ACS, or for those with a history of myocardial infarction who are at high risk of developing atherothrombotic events, to prevent atherothrombotic events.

Original Source: Brilinta Met Primary Endpoint in Phase III THALES Trial in Stroke

Original Title: Brilinta (ticagrelor) combined with aspirin significantly reduces the risk of stroke and death after acute ischemic stroke/transient ischemic attack!

Note: The original text has been abridged.

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