跳至主要内容
临床试验/NCT00901030
NCT00901030已完成不适用

The Association Between Perioperative Platelet Inhibition (Function) and Major Adverse Perioperative Cardiac Events in Post Percutaneous Coronary Intervention Patients Undergoing Non-cardiac Surgery

McMaster University6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
6
主要终点
Relationship between platelet function and MACE during the perioperative period

研究概览

简要总结

This study will examine the degree of blood thinning (platelet function) in patients coming for non-cardiac surgery on antiplatelet agents using platelet function tests called thromboelastography (TEG) and platelet mapping assay (PMA) and major cardiac complications that occur any time after surgery (perioperative).

详细描述

Patients who have had stents in their coronary arteries (PCI) have to stay on antiplatelet agents to prevent clotting of their stents. These patients often require non-cardiac surgery (NCS) at some stage after their PCI. The rate of major cardiac complications (MACE)in this population is very high and it is unclear why they are at higher risk than the general population. It is possible their antiplatelet is not adequate, or that surgery causes them to be more clot prone. This is a prospective, multicentre observational study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients between ages 30-85 years old, receiving post-PCI aspirin and/or clopidogrel therapy
  • patients undergoing non-ambulatory, NCS
  • patients will have received a bare metal coronary stent within the last 12 months or a drug eluting stent at any time prior to their NCS
  • the type of surgery has to be such that there are no contra-indictions to remain on an anti-platelet agent
  • surgeon must agree to keep the patient on at least one anti-platelet agent during the perioperative period

排除标准

  • clotting abnormalities
  • drugs affecting platelet function other than aspirin or clopidogrel
  • moderate renal impairment
  • liver dysfunction with co-existing thrombocytopenia

结局指标

主要结局

Relationship between platelet function and MACE during the perioperative period

时间窗: 1 month

次要结局

  • Association of MACE with perioperative platelet function as measured by TEG and PMA(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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