TWILIGHT Will Study Ticagrelor-Alone Therapy for Stent Patients

August 21, 2015—The Icahn School of Medicine at Mount Sinai in New York, New York, announced the launch of the international TWILIGHT clinical trial to test the safety and effectiveness of treating coronary drug-eluting stent patients with the anticlotting medication ticagrelor alone, instead of combining it with aspirin for dual-antiplatelet therapy (DAPT), which is the current standard of care. The investigators 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. AstraZeneca, the manufacturer of ticagrelor, is the study sponsor.

The TWILIGHT trial will enroll up to 9,000 patients at 100 sites across the United States, Canada, Europe, South America, and Asia. Enrollment eligibility includes high-risk patients who are 18 years of age or older and have undergone successful percutaneous coronary intervention with at least one drug-eluting stent and discharged on DAPT with aspirin and ticagrelor for a 3-month duration. After 3 months of being prescribed DAPT, patients will be blindly randomized to start receiving either ticagrelor (90 mg) plus aspirin (81 mg 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.

TWILIGHT’s global Principal Investigator is 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. Usman Baber, MD, who is Director of Clinical Biometrics at the Office of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai, serves as Chair of the TWILIGHT Clinical Coordinating Center.

In the announcement, Dr. Mehran commented, “This global study will re-examine the traditional use of DAPT after coronary artery stenting, and determine whether aspirin can be safely withdrawn. 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.”

Dr. Baber added, “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.”