A Phase 4 interventional study of PFO device closure and Aspirin in Migraine and Patent Foramen Ovale, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Phase 4, Interventional, and Treatment
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 460 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: PFO device closure
Drug: Aspirin
Participants randomized into this group will take PFO device closure.
Participants randomized into this group will take aspirin 200mg qd for 6 months.
Responder rate
Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
Time frame: From baseline period to 12-month treatment period
Treatment safety
Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment
Time frame: From baseline period to 12-month treatment period
Migraine days change per month
Change in the mean number of migraine days from baseline to treatment phase.
Time frame: From baseline period to 12-month treatment period
Number of migraine attacks change per month
Change in the mean number of migraine attacks from baseline to treatment phase.
Time frame: From baseline period to 12-month treatment period
Percentage of migraine change
Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.
Time frame: From baseline period to 12-month treatment period
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Chinese Academy of Medical Sciences, Fuwai Hospital