Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale

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

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2025-06-01

Brief Summary

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Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.

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Detailed Description

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Conditions

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Patent Foramen Ovale Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Migraine Medication Group

Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group.

Group Type ACTIVE_COMPARATOR

Metoprolol 25 Mg Oral Tablet

Intervention Type DRUG

Metoprolol 25mg will be provided for the participants twice a day.

Anticoagulation or anti-platelet medication Group 1

Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin.

Group Type EXPERIMENTAL

Aspirin 100mg

Intervention Type DRUG

Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.

Anticoagulation or anti-platelet medication Group 2

Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel.

Group Type EXPERIMENTAL

Clopidogrel 75mg

Intervention Type DRUG

Clopidogrel 75mg will be provided for the participant once a day.

Anticoagulation or anti-platelet medication Group 3

Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban.

Group Type EXPERIMENTAL

Rivaroxaban 20mg

Intervention Type DRUG

Rivaroxaban 20mg will be provided for the participant once a day.

Interventions

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Aspirin 100mg

Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.

Intervention Type DRUG

Metoprolol 25 Mg Oral Tablet

Metoprolol 25mg will be provided for the participants twice a day.

Intervention Type DRUG

Clopidogrel 75mg

Clopidogrel 75mg will be provided for the participant once a day.

Intervention Type DRUG

Rivaroxaban 20mg

Rivaroxaban 20mg will be provided for the participant once a day.

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

Exclusion Criteria

1. Migraine caused by other reason
2. Had TIA/stroke history
3. Hypersensitive or hyposensitive to the study drug
4. With a history of anticoagulation or anti-platelet drug intake 3 month before randomization.
5. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No