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

NCT ID: NCT05561660

Last Updated: 2023-01-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-10-01

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.

Detailed Description

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Conditions

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Migraine Patent Foramen Ovale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PFO closure

Group Type EXPERIMENTAL

PFO device closure

Intervention Type DEVICE

Participants randomized into this group will take PFO device closure.

Shame procedure

Group Type SHAM_COMPARATOR

Aspirin

Intervention Type DRUG

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.

Intervention Type DEVICE

Aspirin

Participants randomized into this group will take aspirin 200mg qd for 6 months.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pan Xiangbin

Project Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangbin Pan, MD

Role: CONTACT

Fengwen Zhang, MD

Role: CONTACT

Facility Contacts

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Xiangbin Pan, MD

Role: primary

Other Identifiers

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2022-1748

Identifier Type: -

Identifier Source: org_study_id

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