The Icahn School of Medicine at Mount Sinai announced the initiation of a trial that will evaluate the safety and efficacy of ticagrelor monotherapy compared with ticagrelor plus aspirin in patients implanted with a coronary stent.
The TWILIGHT trial will include up to 9,000 high-risk patients enrolled at 100 sites in the United States, Asia, Canada, Europe and South America. Eligible patients include those who underwent successful PCI involving one or more drug-eluting stents, and had been receiving 3 months of dual antiplatelet therapy (DAPT) with aspirin and ticagrelor (Brilinta, AstraZeneca) following discharge. Following the 3-month DAPT regimen, patients will be randomly assigned to receive 90-mg ticagrelor with 80-mg aspirin or placebo daily for 12 months. The trial endpoints will include death, MI, stroke and clinically relevant bleeding, according to a press release.
The trial is designed to study the potential of ticagrelor use to reduce clotting without the increased bleeding risk associated with combination therapy with aspirin, according to the release.
“This innovative clinical trial will provide novel insights on an antiplatelet strategy in high-risk patients that we hypothesize will simultaneously reduce bleeding while maintaining anti-ischemic efficacy, thereby improving net clinical benefit over current standard of care,” Usman Baber, MD, MS, chair of the TWILIGHT clinical coordinating center and director of clinical biometrics at the Office of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai, said in the release.
Disclosure: The TWILIGHT study is funded by AstraZeneca. The principal investigator reports serving as a consultant and advisory board member for AstraZeneca.