NCT05546320

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

COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Patent Foramen Ovale
• Migraine

Interventions

Type	Name	Description
DRUG	Aspirin 100mg	Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.
DRUG	Metoprolol 25 Mg Oral Tablet	Metoprolol 25mg will be provided for the participants twice a day.
DRUG	Clopidogrel 75mg	Clopidogrel 75mg will be provided for the participant once a day.
DRUG	Rivaroxaban 20mg	Rivaroxaban 20mg will be provided for the participant once a day.

Timeline

• Start date: 2022-10-15
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2022-09-19
• Last updated: 2023-01-11

Locations

1 site across 1 country: China