Ticagrelor (Brilinta, AstraZeneca), a direct-acting P2Y12 platelet inhibitor, doesn't appear to be significantly more effective than aspirin in preventing major vascular events in stroke patients, according to topline results released by the company.
The randomized, double-blind, multicenter SOCRATES trial compared the effect of 90 days of treatment with ticagrelor, 90 mg twice daily, or acetylsalicylic acid (aspirin), 100 mg once daily. The primary outcome was the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients who had experienced an acute ischemic stroke or transient ischemic attack (TIA).
Ticagrelor is in a chemical class called the cyclo-pentyl-triazolo-pyrimidines and works by inhibiting platelet activation. It has been shown to reduce the rate of thrombotic cardiovascular (CV) events, such as MI or CV death, in patients with acute coronary syndrome (ACS).
Despite fewer major vascular events in study patients taking ticagrelor than in those receiving aspirin, the trend did not reach statistical significance, a statement from the company notes.
On the basis of preliminary analyses, safety data are consistent with the known safety profile of ticagrelor, said the release. A recent report raised some anecdotal concern about dyspnea in patients prescribed ticagrelor.
The company plans to present the full analysis of the trial results, including subgroups, at an upcoming stroke congress. It also aims to "engage with regulatory agencies on the interpretation of the data," said Jean Bohen, executive vice president, global medicines development, and chief medical officer, AstraZeneca, in the company statement.
The SOCRATES (acute Stroke Or transient isChemic attack tReated with Aspirin or Ticagrelor and patient outcomES) trial included patients aged 40 years and older with an acute ischemic stroke (National Institutes of Health Stroke Scale score of5 or less) or TIA (ABCD2 [age, blood pressure, clinical features, duration, diabetes] score of 4 or greater). Patients randomly assigned into the trial were required to have had symptom onset within 24 hours.
At inception, SOCRATES had an estimated enrollment of 13,600 at more than 500 study locations. It is one of the largest international randomized controlled trials to enroll both stroke and TIA patients within 24 hours of a primary event.
The trial is part of PARTHENON, AstraZeneca's largest CV outcomes program, which involves nearly 80,000 patients at high risk for CV events because of their underlying disease.
The PARTHENON program includes five key studies covering broad patient populations, including those with:
Coronary artery disease (PEGASUS-TIMI 54);
Type 2 diabetes, which is associated with a high risk for CV events (THEMIS); and
Peripheral arterial disease (EUCLID).
Data from the ongoing EUCLID trial are expected later this year.
Ticagrelor is already approved for several indications. According to the company, a 90-mg dose of ticagrelor is indicated to reduce the rate of thrombotic CV events in patients with ACS, unstable angina, non–ST-segment elevation MI, or ST-segment elevation MI. A 60-mg dose is indicated for the treatment of patients who experienced an MI at least 1 year previously and are at high risk for a further atherothrombotic event.
Treatment with 60 mg may be started as continuation therapy after an initial 1-year treatment with 90 mg and aspirin or other dual antiplatelet therapy, the release notes.
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Cite this: Topline Results With Ticagrelor for Secondary Prevention in Stroke - Medscape - Mar 30, 2016.