Project
COBRA REDUCE - Cobra PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated with Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
Completed · 2016 until 2019
Weilenmann Daniel, Schneider Irene
Type
Range
Units
Status
Start Date
End Date
Financing
Study Design
Brief description/objective
Hypothesis: In patients undergoing coronary intervention who are receiving oral anticoagulation, Cobra PzF stents with 14 days of DAPT after stenting provide superior outcomes versus Xience/Promus or Resolute drug-eluting stents with 6 months of DAPT after stenting
Randomization: Treatment allocation to Cobra PzF stents with 14 days of DAPT after stenting versus Xience/Promus or Resolute drug-eluting stents with 6 months of DAPT after stenting in 1:1 ratio
Primary Endpoint: Safety: BARC class ≥2 bleeding after hospital discharge (or beyond 14 days whichever is earlier) at 6 months post-randomization
Clinical follow-up: at 14 days, 1, 6 and 12 months