Migraine Prophylaxis With Clopidogrel Trial

NCT ID: NCT02938182

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2023-10-31

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.

Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clopidogrel

clopidogrel tablet 75mg daily for three months

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

clopidogrel troche 75 mg daily for three months

Interventions

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clopidogrel

clopidogrel troche 75 mg daily for three months

Intervention Type DRUG

Other Intervention Names

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plavix

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guogang Luo, doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guogang Luo, doctor

Role: CONTACT

0086-13991974085

Dan Zhu, master

Role: CONTACT

0086-15229233307

Facility Contacts

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Guogang Luo, doctor

Role: primary

0086-13991974085

Dan Zhu, master

Role: backup

0086-15229233307

Other Identifiers

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XJTU1AF-CRS-2016-019

Identifier Type: -

Identifier Source: org_study_id

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