COBRA REDUCE - Cobra PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated with Oral Anticoagulation Undergoing Percutaneous Coronary Intervention - Projekt

Projekt

COBRA REDUCE - Cobra PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated with Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

Abgeschlossen · 2016 bis 2019

Weilenmann Daniel, Schneider Irene

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Kardiologie

Status

Abgeschlossen

Start

2016

Ende

2019

Finanzierungsart

Industrie

Studiendesign

Prospective, randomized, active-controlled, open-label assignment, assessor-blinded trial at up to 40 Global sites

Kurzbeschreibung/Zielsetzung

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