PFO - Patent Foramen Ovale, Migraine
Conditions
Brief summary
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
Interventions
DEVICEPFO closure device
Device PFO closure.
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
DRUGTriptans
If migraine recurred, Triptans would be administered during the acute phase.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Presence of PFO with right-to-left shunt, confirmed by Transthoracic. 2. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study. 3. Bubble study positive confirmed by transcranial doppler. 4. Subject is diagnosed of migraine. 5. Subject signs an informed Consent Form and is willing to participate in follow-up visits
Exclusion criteria
1. Subject is diagnosed of headache with clear etiology. 2. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding. 3. Brain CT/MR showed ischemic lesions. 4. Subject is diagnosed of hepatic insufficiency: ALT or AST\>3×ULN at the screening visit. 5. Subject is diagnosed of moderate to severe renal insufficiency: eGFR\<30ml/min/1.73m2 at the screening visit. 6. Subject has uncontrolled arrhythmia with clinical significance within 90 days. 7. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days. 8. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis. 9. Subject cannot follow the study procedure due to other acute or chronic diseases. 10. Subject is pregnant or lactating. 11. Subject is under other RCT. 12. Subject has a life expectancy \<1 year. 13. Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete cessation of migraine | Month 12 | Primary Efficacy Endpoint |
| Serious Adverse Event (SAE) related due to device, drug or study procedure | Month 12 | Primary Safety Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monthly migraine attacks | Baseline and Month 12 | Mean change of monthly migraine attacks |
| Monthly migraine days | Baseline and Month 12 | Mean change of monthly migraine days. Monthly migraine days = migraine attacks in one month × average time period per attacks (hours) /24 hours |
| Responder rate | Baseline and Month 12 | Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline |
Countries
China
Outcome results
None listed