Ischemic stroke
Conditions
Interventions
A:use domestic made or imported occluder
oral clopidogrel 50-75mg/daily for one month
aspirin enteric-coated tablets 3mg/kg/d for 6 months
after 6 moths the doctor makes decision whether contineu to use anti-platelet therapy or not
B:Aspirin or warfarin or aspirin+ warfarin
Sponsors
The First Hospital Affiliated to Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16~65 years old; 2. Patients with PFO confirmed by ultrasonic, shunt from right to left confired by acoustical imaging (at calm status/Valsalva action/cough); 3. Patients with ischemic stroke without other causes; 4. Well recovery after ischemic stroke, to be able to perform daily action independently and complete the follow-up visit according to the study protocol.
Exclusion criteria
Exclusion criteria: Patient according to any one item of following will be excluded: 1. Stroke or TIA caused by cerebrovascular and cardiovascular system lesions include: (1) Carotid artery disease: internal carotid artery stenosis (>50%), carotid or vertebral artery dissecting aneurysm; (2) severe valvular heart disease: severe stenosis of mitral valve and aortic valve or vegetations, as well as artificial heart valve; (3) Chronic atrial fibrillation; (4) Suffered acute AMI within past three months, left ventricular aneurysm or Left ventricular ejection score (EF)<30%; (5)uncontrolled diabetes or hypertention; (6) with other diseases which caused shunt from right to left; (7)Blood clots to be confirmed in atrial or ventricular by ultrasonic echocardiography; (8)Complicated with severe collagen vascular disease, giant cell arteritis, vasculitis, systemic necrotizing vasculitis, etc.; 2. Blood clats exists in femoral vein, superior vena cava or right atrium; 3. Patient who in recent(within past six months) or currently intravenous drug abuse; 4. Patient complicated with active infectious endocarditis or confirmed sepsis (transient infection patient can be recruited after four weeks of stop to use antibiotics and without infection symptoms); 5. Patients complicated with active peptic ulcer and upper gastrointestinal bleeding, obvious retinopathy (bleeding and seepage) as well as intracranial hemorrhage; 6. Others: pregnance women, has implanted permanent cardiac pacemaker, PFO not allowed to be shut down, etc.; 7. Patient allergic to asprin, clopidogrel, and warfarin; 8. The anatomical location not suitable for closure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of fatal stroke or early all cause death;Recurrence rate of non fatal stroke;Recurrence rate of TIA;Treatment related clinical deterioration event such as suden death, recurrence of stroke, major vascular complications, atrial fibrillation, severe bleeding (including pericardial tamponade), pulmonary embolism, atrial thrombosis, etc; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of AMI or peripheral artery embolism;Prevalence of cardiac arrhythmias (for example atrial fibrillation);Re-hospitalization due to PFO or related to the treatment used;Occluder related problems (residual shunt or Displacement or deformation or infection or blood clots formed); | — |
Countries
China
Contacts
Public ContactZhang Yushun
Outcome results
None listed