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临床试验/EUCTR2018-001013-32-ES
EUCTR2018-001013-32-ES进行中(未招募)1 期

ANTITHROMBOTIC THERAPY AFTER LEFT ATRIAL APPENDAGE OCCLUSION: DOUBLE ANTIPLATELET THERAPY VS. APIXABAN - ADALA

HOSPITAL CLÍNIC BARCELONA0 个研究点目标入组 160 人开始时间: 2018年8月10日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
160

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age> 18 years
  • NVAF (paroxysmal, persistent or permanent)
  • CHADS2 score =1 or CHA2DS2-VASc score =2
  • * Adequate anatomy for LAA closure and contraindication for OAC (absolute or relative).
  • Able to give informed consent and to be followed-up (phone and clinical visit)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 24
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 136

排除标准

  • Patients with mechanical prostheses, evidence of thrombus, complex aortic atheroma or symptomatic carotid disease
  • Contraindication for TEE studies
  • Platelets <40000
  • Absolute contraindication to Apixaban for 3 months (severe renal failure with Cl. creat <15 ml / h or severe liver disease Child B or C) or allergy to the drug.
  • Contraindication to any form of anticoagulation or antiplatelet therapy.
  • Patients with a history of drug or alcohol abuse, or psychosocial reasons that preclude the follow-up of the patient.
  • Women of childbearing potential (WOCB)

研究者

发起方
HOSPITAL CLÍNIC BARCELONA

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