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Migraine Prophylaxis With Clopidogrel Trial

Primary Purpose

Migraine

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
clopidogrel
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clopidogrel

Arm Description

clopidogrel tablet 75mg daily for three months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Headache Frequency per Month at three months, time
Change from Baseline Visual Analogue Scale at three months, scores
Change from Baseline Migraine Disability Assessment Scale at three months, scores
Change from Baseline Headache Impact Test at three months, scores

Full Information

First Posted
October 17, 2016
Last Updated
August 23, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT02938182
Brief Title
Migraine Prophylaxis With Clopidogrel Trial
Official Title
A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clopidogrel
Arm Type
Experimental
Arm Description
clopidogrel tablet 75mg daily for three months
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
plavix
Intervention Description
clopidogrel troche 75 mg daily for three months
Primary Outcome Measure Information:
Title
Change from Baseline Attack Duration of Headache at three months, h
Time Frame
three months
Secondary Outcome Measure Information:
Title
Change from Baseline Headache Frequency per Month at three months, time
Time Frame
three months
Title
Change from Baseline Visual Analogue Scale at three months, scores
Time Frame
three months
Title
Change from Baseline Migraine Disability Assessment Scale at three months, scores
Time Frame
three months
Title
Change from Baseline Headache Impact Test at three months, scores
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guogang Luo, doctor
Phone
0086-13991974085
Email
lguogang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Zhu, master
Phone
0086-15229233307
Email
767441726@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guogang Luo, doctor
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guogang Luo, doctor
Phone
0086-13991974085
Email
lguogang@163.com
First Name & Middle Initial & Last Name & Degree
Dan Zhu, master
Phone
0086-15229233307
Email
767441726@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The information of the patients need to keep confidential.

Learn more about this trial

Migraine Prophylaxis With Clopidogrel Trial

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