Migraine Prophylaxis With Clopidogrel Trial

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Migraine

Treatments: Drug: clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02938182

XJTU1AF-CRS-2016-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

clopidogrel

Experimental group

Description:

clopidogrel tablet 75mg daily for three months

Treatment:

Drug: clopidogrel