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

Study Overview
=================
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.

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

Conditions
-----------------
Patent Foramen Ovale, Migraine

Intervention / Treatment
-----------------
* Drug: Aspirin 100mg
* Drug: Metoprolol 25 Mg Oral Tablet
* Drug: Clopidogrel 75mg
* Drug: Rivaroxaban 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 ； Diagnosed migraine by ICHD-3 History of migraine longer than 1 year TCD/TTE/TEE diagnosed patent foramen ovale Willing to participant and agree to follow-ups Exclusion Criteria: Migraine caused by other reason Had TIA/stroke history Hypersensitive or hyposensitive to the study drug With a history of anticoagulation or anti-platelet drug intake 3 month before randomization. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Migraine Medication Group<br>Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group. | Drug: Metoprolol 25 Mg Oral Tablet<br>* Metoprolol 25mg will be provided for the participants twice a day.<br>|
| Experimental: Anticoagulation or anti-platelet medication Group 1<br>Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin. | Drug: Aspirin 100mg<br>* Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.<br>|
| Experimental: Anticoagulation or anti-platelet medication Group 2<br>Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel. | Drug: Clopidogrel 75mg<br>* Clopidogrel 75mg will be provided for the participant once a day.<br>|
| Experimental: Anticoagulation or anti-platelet medication Group 3<br>Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban. | Drug: Rivaroxaban 20mg<br>* Rivaroxaban 20mg will be provided for the participant once a day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Treatment safety | Adverse events after medication treatment | From baseline period to 3-month treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Patent Foramen Ovale, Medication therapy