Platelet Aggregation Inhibitors Clinical Trial
Official title:
MONET BRIDGE(Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery) - (Mantenimento Della Terapia Antiaggregante Nei Pazienti Portatori di Stent Coronarico Candidati a Chirurgia)
The MONET BRIDGE study is designed to assess the use of cangrelor as a platelet-inhibiting bridge for patients who discontinue DAPT before cardiac and non cardiac surgery within 12 months from coronary stent implantation. It seeks to determine if initiation of a prolonged cangrelor infusion maintains effective platelet inhibition after discontinuation of P2Y12 and whether a cangrelor infusion before cardiac and non cardiac procedures is safe.
This will be a randomized, double-blind, placebo-controlled study enrolling patients with
coronary stent, still on DAPT, undergoing cardiac and non cardiac surgery within 12 months
from coronary stent implantation.
The MONET BRIDGE study is designed to assess the use of cangrelor as a platelet-inhibiting
bridge for patients who discontinue DAPT before cardiac and non cardiac surgery within 12
months from coronary stent implantation. It seeks to determine if initiation of a prolonged
cangrelor infusion maintains effective platelet inhibition after discontinuation of P2Y12 and
whether a cangrelor infusion before cardiac and non cardiac procedures is safe.
The primary efficacy objective of this study is to demonstrate that a cangrelor infusion will
maintain levels of residual platelet reactivity (PRU < 208) as measured by Accriva VerifyNow®
P2Y12 assay.
The main safety objective is to demonstrate that patients receiving cangrelor infusion before
cardiac and non cardiac surgery have an acceptable safety profile and can undergo surgery
without excessive bleeding peri-operatively.
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