COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
NCT ID: NCT05561660
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
460 participants
INTERVENTIONAL
2022-10-01
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PFO closure
PFO device closure
Participants randomized into this group will take PFO device closure.
Shame procedure
Aspirin
Participants randomized into this group will take aspirin 200mg qd for 6 months.
Interventions
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PFO device closure
Participants randomized into this group will take PFO device closure.
Aspirin
Participants randomized into this group will take aspirin 200mg qd for 6 months.
Eligibility Criteria
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Inclusion Criteria
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
2. Had TIA/stroke history
3. Hypersensitive or hyposensitive to the study drug
18 Years
65 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Pan Xiangbin
Project Manager
Locations
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Fuwai Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-1748
Identifier Type: -
Identifier Source: org_study_id
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