The Icahn School of Medicine at Mount Sinai has launched an international clinical trial called TWILIGHT to test the safety and effectiveness of treating coronary stent patients with the anti-clotting medication ticagrelor alone, instead of combining it with aspirin, which is the current standard of care. Researchers will analyze the potential benefits of administering ticagrelor to reduce clotting while at the same time reducing the risk of bleeding associated with the use of both medications.
"This global study will re-examine the traditional use of dual antiplatelet therapy after coronary artery stenting, and determine whether aspirin can be safely withdrawn," says TWILIGHT's Global Principal Investigator Roxana Mehran, MD, Director of the Office of Interventional Cardiovascular Research and Clinical Trials of Mount Sinai Heart and Professor of Cardiology and Population Health Science and Policy at Icahn School of Medicine at Mount Sinai. "Our research team will determine the effectiveness and safety of ticagrelor alone, compared to using ticagrelor plus aspirin, to reduce the occurrence of bleeding and adverse events after cardiac stenting."
"This clinical trial will test the feasibility of withdrawing aspirin in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents," says Samin K. Sharma, MD, Director of Clinical and Interventional Cardiology for the Mount Sinai Health System. "Mount Sinai Heart looks forward to conducting this exciting, large-scale investigation to help improve PCI patient care around the world."
For patients receiving a cardiac stent in a cardiac catheterization laboratory through a minimally invasive PCI procedure, current medical guidelines advise that patients receive dual-antiplatelet therapy (DAPT) with both aspirin and a drug from a class of stronger antiplatelet medications called P2Y12 inhibitors (e.g. ticagrelor). Such medications prevent blood clots that can lead to heart attack or stroke by reducing the ability of platelets, cellular fragments circulating in the blood, to stick to one another and form a clot.
"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," says 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.
The large clinical trial led by Mount Sinai will enroll up to 9,000 study subjects at 100 sites across the United States, Canada, Europe, South America, and Asia. After three months of being prescribed dual-antiplatelet therapy, patients will be blindly randomized to start receiving either ticagrelor (90mg) plus aspirin (81mg daily) for 12 months, or ticagrelor plus placebo. Researchers will track the occurrence of any clinically relevant bleeding, or adverse events such as mortality, heart attack, and stroke.
Patients eligible to enroll in the clinical trial are those high-risk patients 18 years of age or older who have undergone successful PCI with at least one drug-eluting stent and discharged on DAPT with aspirin and ticagrelor for a three-month duration.
"Mount Sinai Heart looks forward to much success with our collaborators here in the United States and around the world for the launch of this pioneering clinical trial," says Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital. "By partnering together globally, we are advancing the care of patients with coronary artery diseases and the field of interventional cardiology."
The drug ticagrelor is made by AstraZeneca, which is providing funding support for the study. Dr. Roxana Mehran (the Principal Investigator in this study) receives financial compensation as a consultant and advisory board member for AstraZeneca (the study sponsor and manufacturer of the study drug ticagrelor).
Mount Sinai Health System