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临床试验/NCT04153591
NCT04153591已完成不适用

Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus

Methodist Health System1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年11月5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
75
试验地点
1
主要终点
Efficacy of the direct oral anti-coagulants

研究概览

简要总结

To describe the prescribing patterns at Methodist Dallas Medical Center (MDMC) for the treatment of newly diagnosed mural thrombus and to determine the efficacy and safety of DOACs apixaban, dabigatran, and rivaroxaban in comparison to warfarin.

With limited treatment guideline consensus, minimal evidence to support the use of DOACs for Left Atrial Appendage (LAA) thrombus and Left Ventricular Thrombus (LVT), and a lack of evidence for the use of DOACs in aortic thrombus, further research is warranted to determine the role of DOACs in the treatment of various mural thrombi in comparison to warfarin.

详细描述

Retrospective chart review of MDMC patients from 4/1/2017 to 8/31/19 with newly diagnosed mural thrombus.

3.1. Study Methods

  • Patients will be allocated into two groups: those who were prescribed DOACs upon discharge and those who were prescribed warfarin upon discharge
  • Subgroup analyses will occur to evaluate the difference in efficacy and safety endpoints for patients into four categories including: those predisposed to mural thrombus by baseline risk factors (AFIB vs. ACS), location of the mural thrombus (atrial, ventricular, aortic), DOAC by agent (apixaban, rivaroxaban, dabigatran), and DOAC by scheduled dosing indication (AFIB vs. VTE).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Age ≥ 18 years
  • MHS patients with newly diagnosed mural thrombus from 4/1/2017 to 8/31/19 identified by International Classification of Diseases (ICD) codes: I23.6, I240, I513, I7409, I7411, I7419, I82210, I82229

排除标准

  • Age <18 years
  • Anticoagulant use at baseline (DOAC, LMWH, VKA)
  • Active cancer
  • Active bleeding
  • Hospice or palliative care upon discharge
  • Warfarin that did not receive adequate bridging from parenteral anticoagulation
  • Non newly diagnosed mural thrombus

结局指标

主要结局

Efficacy of the direct oral anti-coagulants

时间窗: from 4/1/2017 to 8/31/19

Readmission for recurrent stroke or thromboembolic event within 90 days of initial hospital discharge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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