Dr. Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI is a Professor of Medicine and the Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine. In this podcast Dr. Mehran discusses Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT).
Link to Abstract-
The goal of this study is to see how ticagrelor alone compares to ticagrelor and aspirin together. Both ticagrelor and aspirin prevent platelets from adhering to one another and forming a blood clot, which might cut off blood flow to the heart. This trial will assess the efficacy and safety of ticagrelor alone with ticagrelor + aspirin in reducing clinically meaningful bleeding and ischemic adverse events in high-risk patients who have had at least one drug-eluting stent percutaneous intervention. If a patient meets particular clinical and/or anatomic criteria, they are deemed high-risk.
At the time of their index PCI, up to 9000 participants will be registered. At 3 months after enrolment, subjects who meet the randomization criteria will be randomized to ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Following enrollment, clinic visits will be scheduled at 3 months, 9 months, and 15 months.
Description in detail:
This is a multicenter, blinded, prospective dual-arm research. Up to 9000 high-risk patients discharged on DAPT with aspirin and ticagrelor for at least 3 months from sites in the United States, Canada, Europe, and Asia who have undergone successful PCI with at least one locally approved drug eluting stent. The primary goal of this trial is to compare the effectiveness of antiplatelet monotherapy with ticagrelor alone against DAPT with ticagrelor plus aspirin for 12 months in preventing clinically meaningful bleeding in high-risk PCI patients who have completed a 3-month course of aspirin plus ticagrelor. The study's secondary goal is to see how effective antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months is in reducing major ischemic adverse events (safety) in high-risk PCI patients who have completed a 3-month course of aspirin plus ticagrelor.
Assessing the comparative safety and efficacy of the various DAPT regimens for particular components of the primary efficacy and secondary safety objectives is one of the exploratory objectives.
The London School of Hygiene and Tropical Medicine will conduct the primary analysis for TWILIGHT on its own.