The Perioperative Management of Anti-thrombotic Drug Registry
追踪信息 | |||
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首次提交日期 ICMJE | August 20, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | January 31, 2018 | ||
预计主要完成日期 | January 31, 2028 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
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) |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | The Perioperative Management of Anti-thrombotic Drug Registry | ||
正式标题 ICMJE | The Perioperative Management of Anti-thrombotic Drug Registry | ||
简要概况 | 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. |
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详细说明 | |||
研究类型 ICMJE | Observational [Patient Registry] | ||
研究阶段 | |||
研究设计 ICMJE | 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: |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
12000 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | January 31, 2028 | ||
预计主要完成日期 | January 31, 2028 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | 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: | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
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 |
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IPD 共享声明 |
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责任方 | Subhash Banerjee,University of Texas Southwestern Medical Center | ||
研究赞助商 ICMJE | Subhash Banerjee | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of Texas Southwestern Medical Center | ||
验证日期 | 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 |