Comparison of three different strategies of preventing a second stroke in patients with a small hole in the wall dividing the right side of the heart from the left side:-two different forms of blood thinning medication: - long-time antiplatelet therapy - long-time anticoagulant therapyor - closure of the hole by implanting a small metal device using a catheter, followed by long-time antiplatelet therapy

Phase 1

Conditions: The study compares different strategies for secondary stroke (or retinal ischaemia) prevention in patients with patent foramen ovale.The three treatment arms comprise: 1. Endovascular patent foramen ovale closure followed by long-term antiplatelet therapy 2. long-term anticoagulant therapy 3. long-term antiplatelet therapy
MedDRA version: 19.0Level: LLTClassification code 10036654Term: PreventionSystem Organ Class: 100000004865
MedDRA version: 19.0Level: LLTClassification code 10016982Term: Foramen ovale patentSystem Organ Class: 100000004850
MedDRA version: 19.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-000110-19-DE

Lead Sponsor: Assistance Publique – Hôpitaux de Paris (AP-HP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

- 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

Exclusion Criteria

- 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