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

Phase 4

Recruiting

• Conditions: Patent Foramen Ovale; Migraine
• Interventions: Drug: Rivaroxaban 20mg; Drug: Metoprolol 25 Mg Oral Tablet; Drug: Aspirin 100mg; Drug: Clopidogrel 75mg

• Registration Number: NCT05546320
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-19
• Study Start: 2022-10-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anticoagulation or anti-platelet medication Group 3	Rivaroxaban 20mg	Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban.
Migraine Medication Group	Metoprolol 25 Mg Oral Tablet	Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group.
Anticoagulation or anti-platelet medication Group 1	Aspirin 100mg	Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin.
Anticoagulation or anti-platelet medication Group 2	Clopidogrel 75mg	Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel.

Primary Outcome Measures

Name	Time	Method
Responder rate	From baseline period to 3-month treatment period	Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
Treatment safety	From baseline period to 3-month treatment period	Adverse events after medication treatment

Secondary Outcome Measures

Name	Time	Method
Migraine days change per month	From baseline period to 3-month treatment period	Change in the mean number of migraine days from baseline to treatment phase.
Number of migraine attacks change per month	From baseline period to 3-month treatment period	Change in the mean number of migraine attacks from baseline to treatment phase.
Percentage of migraine change	From baseline period to 3-month treatment period	Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China