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Migraine Prophylaxis With Clopidogrel Trial

Phase 4UnknownNCT02938182
First Affiliated Hospital Xi'an Jiaotong University50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

50

Conditions

Migraine

Interventions

clopidogrelDRUG

clopidogrel troche 75 mg daily for three months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years
Medical Language ↔ Plain English
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

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline Attack Duration of Headache at three months, h

Time frame: three months

Secondary Outcomes

Change from Baseline Headache Frequency per Month at three months, time

Time frame: three months

Change from Baseline Visual Analogue Scale at three months, scores

Time frame: three months

Change from Baseline Migraine Disability Assessment Scale at three months, scores

Time frame: three months

Change from Baseline Headache Impact Test at three months, scores

Time frame: three months

Central Contacts

Guogang Luo, doctor

CONTACT

0086-13991974085lguogang@163.com

Dan Zhu, master

CONTACT

0086-15229233307767441726@qq.com
Data from ClinicalTrials.gov

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