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
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