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)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 主要终点
- LEVEL OF RESIDUAL PLATELET REACTIVITY
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cangrelor
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
干预措施: Cangrelor (Drug)
结局指标
主要结局
LEVEL OF RESIDUAL PLATELET REACTIVITY
时间窗: 1-2 hours
Accriva VerifyNow P2Y12 assay
次要结局
- ischemic and hemorrhagic endpoints(30 days)
研究者
ROBERTA ROSSINI
Principal Investigator
Ospedale Santa Croce-Carle Cuneo