Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT)
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.
|Cardiovascular Disease Interventional Cardiology||Drug: Aspirin Drug: Placebo Drug: ticagrelor||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
|Official Title:||Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention|
- Bleeding episode [ Time Frame: 12 months ]the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding.
- Ischemic episode [ Time Frame: 12 months ]the time to first occurrence of confirmed cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2019 (Final data collection date for primary outcome measure)|
Active Comparator: Aspirin + Ticagrelor
enteric coated aspirin 81mg daily p.o. for 12 months and ticagrelor 90mg tablet bid for 15 months
Other Name: EcotrinDrug: ticagrelor
Placebo Comparator: Placebo + Ticagrelor
placebo pill daily p.o. for 12 months - match for enteric coated aspirin 81mg and ticagrelor 90mg tablet bid for 15 months
This is a multicenter, prospective, blinded dual-arm study. 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 with aspirin and ticagrelor of at least 3 months intended duration from centers still to be determined in the U.S., Canada, Europe and Asia. 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 (efficacy) among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.
The secondary 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 major ischemic adverse events (safety) among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.
Exploratory objectives include assessing the comparative safety and efficacy of the different DAPT regimens for individual components of the primary efficacy and secondary safety objectives.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02270242
|Contact: Pamela Kivitz||212-659-8372||Pamela.Kivitz@mountsinai.org|
|Contact: Theresa Franklin-Bond, PA-Cemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Roxana Mehran, MD|
|Study Director:||Roxana Mehran, MD||Icahn School of Medicine at Mount Sinai|
|Study Chair:||Usman Baber, MD||Icahn School of Medicine at Mount Sinai|