Effectivity and safety of PFO closure vs medicine in alleviating migraine (SPRING): a multicenter, random, case control study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Device PFO closure.
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
If migraine recurred, Triptans would be administered during the acute phase.
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Complete cessation of migraine
Primary Efficacy Endpoint
Time frame: Month 12
Serious Adverse Event (SAE) related due to device, drug or study procedure
Primary Safety Endpoint
Time frame: Month 12
Monthly migraine attacks
Mean change of monthly migraine attacks
Time frame: Baseline and Month 12
Monthly migraine days
Mean change of monthly migraine days. Monthly migraine days = migraine attacks in one month × average time period per attacks (hours) /24 hours
Time frame: Baseline and Month 12
Responder rate
Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline
Time frame: Baseline and Month 12
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Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
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The Eighth Affiliated Hospital, Sun Yat-sen University
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Huizhou First People's Hospital
Huizhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
The First People's Hospital of Nanning
Nanning, Guangxi, China
...and 11 more locations