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The Perioperative Management of Anti-thrombotic Drug Registry

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合作者:
信息的提供 (责任方):
Subhash Banerjee,University of Texas Southwestern Medical Center
August 20, 2018
October 3, 2018
October 3, 2018
January 31, 2018
January 31, 2028   (主要结果测量的最终数据收集日期)
Clinical Outcomes (Net Adverse Cardiovascular events (%))[ Time Frame: 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)

与当前相同
  • [ Time Frame: ]
 
The Perioperative Management of Anti-thrombotic Drug Registry
The Perioperative Management of Anti-thrombotic Drug Registry

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.

Observational [Patient Registry]
分配:
干预模型:
干预模型描述:
盲法: Observational [Patient Registry]
盲法描述:
主要目的:
  • :
  • :
 
Recruiting
12000
与当前相同
January 31, 2028
January 31, 2028   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - 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) Exclusion Criteria:
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
United States
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: No
Subhash Banerjee,University of Texas Southwestern Medical Center
Subhash Banerjee
Study Chair: Subhash Banerjee, MD UT Southwestern Medical Center
University of Texas Southwestern Medical Center
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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