Minimally Invasive Coronary Artery Bypass Supported by Cangrelor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Excessive CABG-related bleeding during and after MIDCAB surgery
研究概览
简要总结
The purpose of this study is to find out whether it is safe and practical to perform MIDCAB surgery (a minimally invasive heart bypass procedure) while patients receive a continuous cangrelor infusion during the operation. Cangrelor is a medicine that helps prevent blood clots and works quickly through a vein drip.
The study compares patients receiving cangrelor during surgery to patients who had the same surgery in the past while on aspirin, with or without cangrelor given beforehand.
Study Question: Can MIDCAB surgery be safely performed under cangrelor infusion, without increasing the risk of bleeding or other complications?
Hypothesis: Using cangrelor during MIDCAB surgery is safe and feasible, and it provides effective protection against blood clots during the procedure.
This study will help doctors understand whether intraoperative cangrelor can improve patient safety and outcomes in minimally invasive heart surgery.
详细描述
Study Design Overview The MINOTAUR study is an open-label, single-center, case-control study assessing patients undergoing MIDCAB surgery under continuous cangrelor infusion at 0.75 μg/kg/min compared with historical controls who underwent the same procedure under aspirin therapy with or without prior cangrelor bridging. The study is exploratory and aims to evaluate safety, feasibility, and procedural aspects of intraoperative cangrelor use.
Prospective Arm: Study Intervention and Procedures
Cangrelor Administration: Prior oral antiplatelet therapies are discontinued. Cangrelor infusion is initiated based on daily platelet function testing (Multiplate®) to achieve adequate platelet inhibition before surgery.
Surgical Procedure: MIDCAB is performed ≥24 hours after cangrelor initiation, with intraoperative anticoagulation using unfractionated heparin monitored by activated clotting time.
Perioperative Monitoring: Includes daily assessment of platelet function, vital signs, ECG parameters, cardiac biomarkers (high-sensitivity troponin), and laboratory chemistry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •for the historical control arm:
- •Age ≥18 years old
- •CABG with IMA-LAD graft in MIDCAB technique
- •Inclusion criteria for the prospective arm:
- •Age ≥18 years old
- •CABG with IMA-LAD graft in MIDCAB technique
- •Signed informed consent
排除标准
- •for the historical control arm
- •Administration of fibrinolytics or GP IIb/IIIa inhibitors
- •Previous intracranial hemorrhage
- •Known bleeding diathesis
- •Patients undergoing concomitant PCI and MIDCAB
- •Severe renal or liver disease
- •Pregnancy or breast feeding
- •Exclusion criteria for the prospective arm
- •Unconsciousness
- •Known hypersensitivity to study drug (cangrelor)
- •Recent administration of fibrinolytics or GP IIb/IIIa inhibitors
- •Previous intracranial hemorrhage
- •Known bleeding diathesis
- •Patients undergoing concomitant PCI and MIDCAB
- •Severe renal or liver disease
- •Pregnancy or breast feeding
研究组 & 干预措施
Aspirin MIDCAB Group (Historical Controls)
Retrospective patients who previously underwent MIDCAB surgery under aspirin therapy, with or without prior bridging with cangrelor. Relevant perioperative and clinical data are extracted from the institutional database for comparison with the prospective cases.
干预措施: Aspirin MIDCAB surgery (for the historical controls) (Procedure)
Cangrelor MIDCAB Group (Prospective Cases)
Patients prospectively enrolled to undergo MIDCAB surgery while receiving continuous cangrelor infusion at 0.75 μg/kg per minute. All prior oral antiplatelet therapy is discontinued, and platelet function is monitored daily with Multiplate® testing. Data collected include perioperative safety, bleeding outcomes, laboratory values, and clinical events.
干预措施: Cangrelor-guided MIDCAB surgery (for the prospective cases) (Procedure)
结局指标
主要结局
Excessive CABG-related bleeding during and after MIDCAB surgery
时间窗: From the start of surgery through 24 hours postoperatively
Excessive bleeding is defined as the occurrence of at least one of the following: (1) bleeding requiring surgical re-exploration, (2) 24-hour chest tube output greater than 1 liter, or (3) transfusion of more than 4 units of packed red blood cells. This measure assesses the safety of cangrelor-guided MIDCAB compared with historical aspirin-treated controls.
次要结局
- In-hospital MACCE(From surgery through hospital discharge, an average of 8 days)
- Probable or Defined Stent Thrombosis(From surgery through hospital discharge, an average of 8 days)
- Cardiac Injury (High-Sensitivity Troponin)(Preoperative baseline until hospital discharge, an average of 10 days)
- Chest Tube Output(6, 12, 24, and 48 hours postoperatively)
- Blood Transfusion Requirements and Nadir Hemoglobin(From surgery through hospital discharge, an average of 8 days)
- ICU Length of Stay and Mechanical Ventilation Duration(From ICU admission post-surgery to ICU discharge, an average of 12-24 hours)
- BARC-4 Bleeding and Universal Definition of Perioperative Bleeding(From surgery through hospital discharge, an average of 8 days)
- Acute Kidney Injury and Renal Replacement Therapy(From surgery through hospital discharge, an average of 8 days)
- Length of Hospital Stay(From Surgery to hospital discharge, an average of 10 days)
- Platelet Function Under Cangrelor Infusion(From initiation of cangrelor infusion until hospital discharge, an average of 10 days)
- Vital Signs and 12-lead ECG Parameters(From surgery through hospital discharge, an average of 8 days)
- Standard Hematology and Blood Chemistry(Preoperative baseline through hospital discharge, an average of 10 days)
研究者
Marco Valgimigli
Cardiology Chief Prof. Dr. Med
Cardiocentro Ticino