Clinical trial NCT02938182: Migraine Prophylaxis With Clopidogrel Trial
Official title: A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Migraine
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Attack Duration of Headache at three months, h
timeFrame: three months
Secondary outcomes:
measure: Change from Baseline Headache Frequency per Month at three months, time
timeFrame: three months
measure: Change from Baseline Visual Analogue Scale at three months, scores
timeFrame: three months
measure: Change from Baseline Migraine Disability Assessment Scale at three months, scores
timeFrame: three months
measure: Change from Baseline Headache Impact Test at three months, scores
timeFrame: three months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guogang Luo, doctor
role: PRINCIPAL_INVESTIGATOR
References: