The American regulator has approved a new indication for ticagrelor – stroke prevention after ischemic stroke or high-risk transient ischemic attack (TIA). In studies, the combination of the drug with acetylsalicylic acid was superior to monotherapy.
The US Food and Drug Administration (FDA) has approved ticagrelor to reduce the risk of stroke in patients with a previous ischemic stroke or high-risk TIA, MedScape reports.
The decision on a new indication for the drug is based on the positive results of the international THALES study. According to the trial results, the use of ticagrelor in combination with acetylsalicylic acid (ASA) achieved a reduction in the risk of stroke and death compared with ASA monotherapy, mainly due to a reduction in the incidence of ischemic strokes. Therapy was started soon after ischemic stroke or TIA.
Previously, based on the results of another large-scale study, the FDA approved the use of a combination of ticagrelor and ASA for the primary prevention of heart attack and stroke.
In Russia, the drug in combination with ASA is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome, as well as the prevention of atherothrombotic complications in patients with a history of myocardial infarction and a high risk of developing such a complication. This follows from the State Register of Medicines.