At a glance
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A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
In Brief
A Phase 4 clinical trial evaluating PROMUS Element Plus Coronary Stent System, Aspirin, and 1 other intervention for Coronary Artery Disease. Completed, enrolled 2,681 participants across 52 sites.
Detailed Summary
This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.
Study Details
Timeline
Interventions
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).
Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI. * Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily) * Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling) * Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses \>100 mg may reduce ticagrelor effectiveness and should be avoided. * Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)