Study ID: EVOLVE
EVOLVE Short DAPT Study
Researchers are assessing the safety of three-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding and who have undergone implantation of the SYNERGY Stent System. Participants will be expected to complete follow-up visits for 15 months post procedure.
This multicenter, single-arm study is designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System).
Subjects must be treated for 3 months following the index procedure with one of the following P2Y12 inhibitors: clopidogrel, prasugrel or ticagrelor. Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria:
- Subject was treated with 3 months of study-required DAPT post index procedure
- Subject was free from events (stroke, MI, PCI, coronary artery bypass graft), and stent thrombosis between the index procedure and the 3-month visit
Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met:
- Subject experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit)
- Subject who is non-compliant with study-required DAPT during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit)
- Subject is judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use.
Subjects must also be treated with aspirin for the trial’s duration. The minimum daily maintenance dose of aspirin should be 75-100 mg.
All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through 15 months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month milestone, subjects who experience MI or stent thrombosis events should be treated per the investigator’s discretion and should be followed through the 15-month visit.
- Must have had the SYNERGY stent system implanted and be deemed at high risk for bleeding
- Must be able to take a P2Y12 inhibitor for three months post procedure and a low-dose aspirin daily for the duration of the 15-month trial