Migraine Prophylaxis With Clopidogrel Trial

Study Overview
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Brief Summary
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The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Detailed Description
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Many studies have shown an increased prevalence of right-to-left shunts in migraineurs. The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. In the present study, migraineurs without taking prophylactic medicines regularly will be given only clopidogrel 75 mg daily for three months. Migraineurs who are unresponsive to at least two commonly applied preventive medications, clopidogrel 75 mg daily will be added to his/her existing prophylactic migraine regimen for three months. Patients will be followed up at the third month and the sixth month for headache frequency, attack duration of headache, migraine disability assessment scale（MIDAS）scores, headache impact test（HIT-6）scores and visual analogue scale（VAS）scores. Investigators will evaluate the changes of these measurements between baseline and the follow-up time. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Official Title
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A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt

Conditions
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Migraine

Intervention / Treatment
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* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: migraine with or without aura diagnosed by a neurologist according to the criteria of the International Headache Society (3nd edition) experience a minimum of two migraine attacks per month in a 3-month baseline phase without regular use of prophylactic treatments or unresponsive to two and more commonly applied preventive medications the presence of RLS confirmed by contrast-enhanced transcranial Doppler no positive findings in cranial CT and MRI Exclusion Criteria: other types of headaches systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function history of head injury other contraindications to clopidogrel treatment

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clopidogrel<br>clopidogrel tablet 75mg daily for three months | Drug: clopidogrel<br>* clopidogrel troche 75 mg daily for three months<br>* Other names: plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Attack Duration of Headache at three months, h |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Headache Frequency per Month at three months, time |  | three months | 
| Change from Baseline Visual Analogue Scale at three months, scores |  | three months | 
| Change from Baseline Migraine Disability Assessment Scale at three months, scores |  | three months | 
| Change from Baseline Headache Impact Test at three months, scores |  | three months |