跳至主要内容
临床试验/NCT04362020
NCT04362020Unknown不适用

Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants

University of Luebeck0 个研究点目标入组 400 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
主要终点
Occurrence of postprocedural radial artery occlusion

研究概览

简要总结

To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Clinical indication to perform diagnostic coronary angiography
  • Pretreatment with oral anticoagulants (phenprocoumon or direct oral anticoagulants [dabigatran, apixaban, rivaroxaban, or edoxaban])
  • Age > 18 years
  • Written informed consent

排除标准

  • Already administered additional anticoagulation prior to coronary angiography
  • Planned coronary intervention
  • Preexisting radial artery occlusion or missing pulse at the potential puncture sites
  • Allergy / intolerance to anticoagulants
  • Active bleeding or comorbidity with elevated bleeding risk
  • Pregnancy
  • Inability to sign informed consent
  • Participation in another trial

结局指标

主要结局

Occurrence of postprocedural radial artery occlusion

时间窗: Day 1

Will be the occurrence of postprocedural radial artery occlusion assessed with high-resolution vascular ultrasound. Experienced sonographers will perform color Doppler ultrasound in all study patients after removal of the compression device to examine the radial, ulnar, and brachial arteries of the access forearm.

次要结局

  • Sonographic characteristics of radial artery occlusion(3 Month)

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Ingo Eitel

Director

University of Luebeck

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