A Phase 2 interventional study of Cangrelor in Platelet Aggregation Inhibitors, sponsored by Ospedale Santa Croce-Carle Cuneo. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Ospedale Santa Croce-Carle Cuneo · Phase 2, Interventional, and Treatment
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.
Ospedale Santa Croce-Carle Cuneo is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cangrelor, 0.75 μg/Kg/min, a cangrelor infusion will be started in addition to SOC when the P2Y12 inhibitor has been discontinued after the need for surgery has been determined. The infusions (cangrelor or matching placebo) will continue throughout the pre-operative period
Drug: Cangrelor
patients will receive only standard of care, in which the P2Y12 inhibitor is discontinued after the need for surgery has been determined and a placebo infusion is administered
Cangrelor is an intravenous analog of adenosine triphospate with a potent, selective and specific affinity for P2Y12 receptors.
Also known as: KENGREXAL® (cangrelor)
LEVEL OF RESIDUAL PLATELET REACTIVITY
Accriva VerifyNow P2Y12 assay
Time frame: 1-2 hours
ischemic and hemorrhagic endpoints
Bleeding Academic Research Consortium (BARC) grade \> 3
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Ospedale Santa Croce-Carle Cuneo