The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
996
BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").
Time frame: 6 months
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke
Time frame: 6 months
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke
Time frame: 12 months
Composite of cardiac death and myocardial infarction
Time frame: 12 months
Ischemia driven target lesion revascularization
Time frame: 12 months
Definite and probable stent thrombosis
Time frame: 12 months
Ischemic stroke
Time frame: 12 months
BARC class 3-5 bleeding
Time frame: 6 months
TIMI major bleeding; TIMI major and minor bleeding
Time frame: 6 months
Acute Success Rates
Device success; Lesion success; Procedure success
Time frame: procedure
Health economic utility
Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Christiana Care Health Services
Newark, Delaware, United States
University of Florida
Jacksonville, Florida, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Sebastian River Medical Center
Melbourne, Florida, United States
Mt Sinai Medical Center
Miami Beach, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Maryland St. Joseph Medical Center
Towson, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
...and 38 more locations
Time frame: 12 months