AstraZeneca has announced that new data from a Phase IV independent trial, TWILIGHT, showed BRILINTA (ticagrelor) monotherapy reduces the possibility of clinically relevant bleeding in high-risk patients who underwent PCI.
The Icahn School of Medicine at Mount Sinai designed and sponsored the study, which also received study drug and funding from AstraZeneca through an investigator-initiated grant.
BRILINTA is an oral, reversibly binding, direct-acting P2Y12 receptor antagonist designed to suppress platelet activation.
The TWILIGHT trial was carried out at 187 sites in 11 countries and the patients enrolled were mostly from the US.
The trial saw 9,006 patients receive 90mg ticagrelor twice daily and 81mg-100mg enteric-coated aspirin daily for three months. Patients had undergone PCI with the insertion of at least one drug-eluting stent (DES).
A total of 7,119 patients remained event-free during the three months of treatment with ticagrelor and aspirin. These subjects were randomised in a double-blind manner to continue aspirin or placebo for 12 more months. Both groups had to continue open-label ticagrelor.
The ticagrelor monotherapy reduced the risk of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding by 44% more than ticagrelor plus low-dose aspirin over one year.
The secondary endpoint of non-inferiority in the risk of myocardial infarction (MI), death or stroke was also achieved.
AstraZeneca Global Medical Affairs vice-president Danilo Verge said: “The benefit of BRILINTA in reducing thrombosis following the placement of a stent is well established and recommended in guidelines in patients with acute coronary syndromes.
“The results from the TWILIGHT trial show that following percutaneous coronary intervention in high-risk patients, the withdrawal of aspirin while continuing ticagrelor monotherapy resulted in a lower bleeding rate, while showing non-inferiority for the risk of composite of death, MI, or stroke versus dual antiplatelet therapy.”