Migraine Prophylaxis With Clopidogrel Trial

Phase 4

• Conditions: Migraine
• Interventions: Drug: clopidogrel

• Registration Number: NCT02938182
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clopidogrel	clopidogrel	clopidogrel tablet 75mg daily for three months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China