Migraine Prophylaxis With Clopidogrel Trial

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02938182
Collaborator
(none)
50
1
1
84
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: clopidogrel

clopidogrel tablet 75mg daily for three months

Drug: clopidogrel
clopidogrel troche 75 mg daily for three months
Other Names:
  • plavix
  • Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Attack Duration of Headache at three months, h [three months]

    Secondary Outcome Measures

    1. Change from Baseline Headache Frequency per Month at three months, time [three months]

    2. Change from Baseline Visual Analogue Scale at three months, scores [three months]

    3. Change from Baseline Migraine Disability Assessment Scale at three months, scores [three months]

    4. Change from Baseline Headache Impact Test at three months, scores [three months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710061

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University

    Investigators

    • Principal Investigator: Guogang Luo, doctor, First Affiliated Hospital Xi'an Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT02938182
    Other Study ID Numbers:
    • XJTU1AF-CRS-2016-019
    First Posted:
    Oct 19, 2016
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2021