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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Enrolling; Phase 4

Conditions: Migraine; Patent Foramen Ovale

Treatments: Device: PFO device closure; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT05561660

2022-1748

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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460 participants in 2 patient groups

PFO closure

Experimental group

Treatment:

Device: PFO device closure

Shame procedure

Sham Comparator group

Treatment:

Drug: Aspirin