Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery (MONET BRIDGE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Platelet Aggregation Inhibitors

Intervention / Treatment
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* Drug: Cangrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent before initiation of any study related procedures. Be ≥ 18 years of age. Have received any dose of a P2Y12 inhibitor (clopidogrel, ticlopidine, prasugrel, or ticagrelor) at any dose within at least 48 hours prior to randomization. Patients undergoing non deferrable cardiac or non cardiac surgery which requires discontinuation of P2Y12 inhibitor due to a significant bleeding risk. Exclusion Criteria: Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females Active bleeding with evident contraindications to DAPT Patients requiring oral anticoagulant therapy PCI within 1 month Intracranial neoplasm or history of intracranial surgery History of bleeding diathesis Thrombocytopenia (platelet count of less than 100,000/µL) Known International Normalized Ratio (INR) greater than 1.5 at screening. Requirement for dialysis treatment (hemodialysis or peritoneal) Estimated Glomeular filtration rate eGFR <30 ml/min Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period Refusal to receive blood transfusion Receipt of fibrinolytic therapy in the 12 hours preceding randomization Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose High likelihood of being unavailable for follow-up Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cangrelor<br>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<br>* Cangrelor is an intravenous analog of adenosine triphospate with a potent, selective and specific affinity for P2Y12 receptors.<br>* Other names: KENGREXAL® (cangrelor);|
| No Intervention: placebo<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LEVEL OF RESIDUAL PLATELET REACTIVITY | Accriva VerifyNow P2Y12 assay | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemic and hemorrhagic endpoints | Bleeding Academic Research Consortium (BARC) grade > 3 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aNtiplatElet Therapy, cangrelor, randomized, DAPT