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临床试验/NCT04611386
NCT04611386已完成不适用

Bursa Postgraduate Hospital

Bursa Postgraduate Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Anti Factor Xa level

研究概览

简要总结

The aim of this study is to evaluate the effect of iohexol as a contrast agent on the anticoagulant activity of oral factor Xa inhibitors.

详细描述

The study included 65 people who underwent contrast computerized tomography (CT). The study patients were divided into 4 groups. Patients in group 1 were using rivaroxaban (20 patients), patients in group 2 were using apixaban (20 patients), patients in group 3 were using edoxaban (20 patients), and group 4 was the control group (5 volunteers). Iohexol (60 ml) was used as a contrast agent. Two tubes were used to collect 2 ml of blood from the patients at 4 hours after the drug dose (rivaroxaban, apixaban, or edoxaban) and 1 hour after the contrast CT (CT was performed 3 hours after the drug was taken). In the control group, at any time and 1 hour after contrast CT, 2 tubes of 2 ml of blood were collected. The anticoagulant properties of rivaroxaban, apixaban, and edoxaban were evaluated using anti-factor Xa levels.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the use of oral factor Xa inhibitors (patients with nonvalvular AF and CHA2DS2-VASc Score ≥2),
  • age of 21-80 years,
  • no contraindications for anticoagulation use,
  • GFR greater than 30,
  • volunteering to participate in the study, and
  • patients who needed to use contrast agent (iohexol) for CT examination. -

排除标准

  • coagulopathy,
  • severe hepatic insufficiency,
  • chronic systemic or inflammatory diseases,
  • patients lighter than 60 kg,
  • malignancy,
  • creatinine value above 1.5 mg/dl, and
  • not providing consent to participate in the study -

研究组 & 干预措施

rivaroxaban group

20 rivaroxaban using patients

干预措施: computerized tomography (Drug)

apixaban group

20 apixaban using patients

干预措施: computerized tomography (Drug)

edoxaban group

20 edoxaban using patients

干预措施: computerized tomography (Drug)

control group

5 control group patients

干预措施: computerized tomography (Drug)

结局指标

主要结局

Anti Factor Xa level

时间窗: 14 days

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

Hasan ARI

Professor Doctor

Bursa Postgraduate Hospital

研究点 (1)

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