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

Study Overview
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Brief Summary
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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.

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

Conditions
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Migraine, Patent Foramen Ovale

Intervention / Treatment
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* Device: PFO device closure
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PFO closure<br> | Device: PFO device closure<br>* Participants randomized into this group will take PFO device closure.<br>|
| Sham Comparator: Shame procedure<br> | Drug: Aspirin<br>* Participants randomized into this group will take aspirin 200mg qd for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | From baseline period to 12-month treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine days change per month | Change in the mean number of migraine days from baseline to treatment phase. | 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. | 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. | From baseline period to 12-month treatment period |