NCT05561660

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

Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	PFO device closure	Participants randomized into this group will take PFO device closure.
DRUG	Aspirin	Participants randomized into this group will take aspirin 200mg qd for 6 months.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-09-30
• Last updated: 2023-01-09

Locations

1 site across 1 country: China