Closure of patent foramen ovale or anticoagulants versus antiplatelet therapy to prevent stroke recurrence - Close

Assistance Publique – Hôpitaux de Paris (AP-HP)0 个研究点目标入组 900 人开始时间: 2011年4月6日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•- age between 18 and 60 years
•- stroke or retinal ischaemia (initial or recurrent) within last 6 months confirmed by
•cerebral imaging regardless of the duration of symptoms
•- Modified Rankin score 3 or lower
•- absence of another identifiable cause of stroke or retinal ischaemia on a thorough
•aetiological work-up
•- PFO with a large shunt (induced or spontaneous shunt > 30 microbubbles, on TTE
•or on TOE) or PFO associated with atrial septal aneurysm on TOE (base of aneurysm
•at least 15 mm and excursion > 10 mm)
•- the patient must be able to give his written consent
•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 900
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- another cause for stroke associated with PFO
•- isolated atrial septum defect or ASD associated with PFO but with a haemodynamically
•significant left-to-right shunt requiring closure
•- previous surgical or endovascular treatment of PFO or ASA
•- known or suspected pregnancy (beta-hCG assay must be performed before inclusion)
•- breastfeeding
•- follow-up impossible or expected poor compliance
•- presence of other medical problems that would either lead to inability to complete the
•study or interfere with the assessment of outcomes
•- participation in another study
•- patient unable to understand the informed consent form
•- contraindication to the drug treatments or endovascular procedure of the study

发起方

Assistance Publique – Hôpitaux de Paris (AP-HP)