COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Aspirin

Criteria

Inclusion Criteria:

Age 18-65 ； Diagnosed migraine by ICHD-3 History of migraine longer than 1 year TCD/TTE/TEE diagnosed patent foramen ovale Willing to participant and agree to follow-ups Undertook medication therapy for three months without a responder rate higher or equal to 50%

Exclusion Criteria:

Migraine caused by other reason Had TIA/stroke history Hypersensitive or hyposensitive to the study drug