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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Enrolling; Phase 4

Conditions: Migraine; Patent Foramen Ovale

Treatments: Drug: Rivaroxaban 20mg; Drug: Aspirin 100mg; Drug: Metoprolol 25 Mg Oral Tablet; Drug: Clopidogrel 75mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05546320

No2022-1758

Details and patient eligibility

About

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.

Enrollment: 1,000 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

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 4 patient groups

Migraine Medication Group

Active Comparator group

Description:

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

Treatment:

Drug: Metoprolol 25 Mg Oral Tablet

Anticoagulation or anti-platelet medication Group 1

Experimental group

Description:

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

Treatment:

Drug: Aspirin 100mg

Anticoagulation or anti-platelet medication Group 2

Experimental group

Description:

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

Treatment:

Drug: Clopidogrel 75mg

Anticoagulation or anti-platelet medication Group 3

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban 20mg