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

Migraine Clinical Trial

— COMPETE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546320
• Other study ID #: No2022-1758
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiangbin Pan
• Phone: 88396666
• Email: panxiangbin[@]fuwaihospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Migraine
• Migraine Disorders
• Patent Foramen Ovale

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate	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.	From baseline period to 3-month treatment period
Primary	Treatment safety	Adverse events after medication treatment	From baseline period to 3-month treatment period
Secondary	Migraine days change per month	Change in the mean number of migraine days from baseline to treatment phase.	From baseline period to 3-month treatment period
Secondary	Number of migraine attacks change per month	Change in the mean number of migraine attacks from baseline to treatment phase.	From baseline period to 3-month treatment period
Secondary	Percentage of migraine change	Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.	From baseline period to 3-month treatment period