Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
Status:
Completed
Trial end date:
2019-07-10
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and
aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and
forming a blood clot that could block blood flow to the heart. This study will look to
determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus
aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events
among high-risk patients who have had a percutaneous intervention with at least one
drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or
anatomic criteria.
Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting
randomization eligibility criteria at 3 months post enrollment will be randomized to either
ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up
clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.