TWILIGHT Study: Ticagrelor with Aspirin or Alone in high risk patients after PCI

CLINICAL TRIAL - CONFIDENTIAL TWLIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention PI: David Moliterno, MD Aim 1: To determine the impact of ticagrelor alone versus ticagrelor plus aspirin in reducing clinically relevant bleeding among high-risk patients who had PCI (percutaneous coronary intervention) with at least one drug-eluting stent. Aim 2: To determine the impact of ticagrelor alone versus ticagrelor plus aspirin in reducing ischemic adverse events at one year among high-risk patients undergoing PCI with at least one drug-eluting stent. Approximately 100 sites in U.S., Canada, South America, and Europe Up to 9000 high-risk patients who have undergone successful elective or urgent PCI with at least one locally approved drug eluting stent discharged on DAPT (dual antiplatelet therapy) with aspirin and ticagrelor of at least 3 months intended duration. The primary objective of this study is to determine the impact of antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months in reducing clinically relevant bleeding among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor. Patients will be screened from the Cath lab and enrolling after their PCI procedure. Patients will all take ticagrelor and aspiring for 3 months. At the 3 month visit, if patients still qualify for study and wish to continue, they will be randomized to either continue aspirin and ticagrelor, or to ticagrelor alone. Ticagrelor will be supplied to the patients through the entire study. At the 12 month visit, the therapy period of the study will end and physicians will treat per their discretion. Patients will be followed for an additional 3 months following end of treatment.