Migraine Prophylaxis With Clopidogrel Trial | NCT02938182

Studies
Migraine Prophylaxis With Clopidogrel Trial

NCT02938182

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Aug 27, 2021Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Migraine

Interventions

clopidogrel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Oct 17, 2016

First Submission Date that Met QC Criteria

Oct 17, 2016

First Posted Date

Oct 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2021

Last Update Posted Date

Aug 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clopidogrel	Experimental	clopidogrel tablet 75mg daily for three months	Drug: clopidogrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clopidogrel	Drug	clopidogrel troche 75 mg daily for three months	clopidogrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline Attack Duration of Headache at three months, h		three months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guogang Luo, doctor	Contact	0086-13991974085		lguogang@163.com
Dan Zhu, master	Contact	0086-15229233307		767441726@qq.com

Overall Officials

Name	Affiliation	Role
Guogang Luo, doctor	First Affiliated Hospital Xi'an Jiaotong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Xi'an Jiaotong University	Recruiting	Xi'an	Shaanxi	710061	China

IPD Sharing Statement Module

Plan to Share IPD

Description

The information of the patients need to keep confidential.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided