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临床试验/NCT03695159
NCT03695159已完成不适用

The Perioperative Management of Anti-thrombotic Drug Registry

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2018年1月31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
288
试验地点
2
主要终点
Clinical Outcomes (Net Adverse Cardiovascular events (%))

研究概览

简要总结

The purpose of the study is to investigate contemporary antiplatelet therapy management of patients referred for non-cardiac and cardiac surgical procedures while on chronic therapy with antiplatelet and/or anticoagulant drugs. These medications are routinely prescribed to patients following percutaneous coronary interventions (PCI), known diagnosis of atrial fibrillation, prosthetic heart valves, transcatheter aortic valve procedures, pulmonary embolism, deep vein thrombosis, peripheral artery revascularization procedures etc. This is a highly relevant and understudied clinical area with no randomized clinical trials or large-scale prospective evidence, except for bridging data with unfractionated heparin (UFH). Most recommendations and guidelines are based on consensus expert opinion. While post-PCI patients, especially those treated with coronary stents are placed on dual antiplatelet agents such as aspirin and P2Y12 blocking agents, performing surgery while on these agents increase the risk of hemorrhagic complications, discontinuation or interruption of dual antiplatelet therapy (DAPT) has been associated with adverse ischemic outcomes secondary to myocardial infarction (MI) and stent thrombosis (ST). Moreover, there is only no clear consensus regarding continuation of aspirin perioperatively in these patients. As in the case of PCI, similar arguments for juxtaposed risks (thrombosis vs. bleeding) can be made for a myriad of clinical situations where chronic (≥45 days) use antiplatelet and anticoagulant medication (together referred to as antithrombotic drugs) are indicated. In addition, there are many procedures and surgeries with different bleeding and ischemic risks that cannot be studies through dedicated randomized studies and a registry collection of such information could provide valuable guidance to providers and patients worldwide.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Treatment with antiplatelet and/or anticoagulant medications for ≥45 days prior to the date of NCS.
  • Patients with planned, urgent or emergent cardiac or non-cardiac surgery or procedure (CNCS)

排除标准

  • 未提供

结局指标

主要结局

Clinical Outcomes (Net Adverse Cardiovascular events (%))

时间窗: time of study reporting initiation (14 days prior to CNCS) to end of study (30 days post-CNCS).

A composite of Death, Non-Fatal MI, Ischemic Stroke, Need for Urgent Coronary Revascularization, and Bleeding (defined by Bleeding Associated Research Consortium- BARC)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Subhash Banerjee

Professor of Medicine

University of Texas Southwestern Medical Center

研究点 (2)

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