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

NCT05546320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Aspirin 300mg

Aspirin 300 mg was administered once daily for 12 weeks.

DRUG

Metoprolol 25mg

Metoprolol 25 mg was administered twice daily for 12 weeks.

DRUG

Clopidogrel 75mg

Clopidogrel 75 mg was administered once daily for 12 weeks.

DRUG

Rivaroxaban 20mg

Rivaroxaban 20 mg was administered once daily for 12 weeks.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Xiangbin Pan · National Center for Cardiovascular Disease, China & Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546320 on ClinicalTrials.gov