BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.
研究概览
简要总结
The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •18 Years of Age
- •Non emergent coronary bypass graft surgery
- •Received a thienopyridine within 48 hours prior to enrollment
排除标准
- •Confirmed or suspected pregnancy
- •Cerebrovascular accident within one yar
- •Intracranial neoplasm
- •History of bleeding diathesis
- •Thrombocytopenia
研究组 & 干预措施
Cangrelor
Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days.
干预措施: cangrelor (Drug)
Placebo
A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.
干预措施: Placebo (Other)
结局指标
主要结局
Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.
时间窗: During study drug infusion up to 1-6 hours prior to surgery
Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).
Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.
时间窗: During study drug infusion up to 1-6 hours prior to surgery
This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events. Patients had multiple samples and all "on-infusion" samples had to be \<240 PRU to meet the endpoint.
次要结局
- Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU(baseline until just prior to surgery (post infusion))
- Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding(Randomization through Hospital discharge)
- Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild(Randomization until start of CABG surgery)
- Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner(Through 7 days or hospital discharge, whichever was sooner)