Migraine Prophylaxis With Clopidogrel Trial

NCT02938182 | Unknown Phase 4

• 1 other identifier: XJTU1AF-CRS-2016-019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

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

  three months

Secondary Outcomes (4)

• 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

Study Arms (1)

clopidogrel

EXPERIMENTAL

clopidogrel tablet 75mg daily for three months

Drug: clopidogrel

Interventions

clopidogrel DRUG

clopidogrel troche 75 mg daily for three months

Also known as: plavix

clopidogrel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other types of headaches
• systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
• history of head injury
• other contraindications to clopidogrel treatment

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guogang Luo, doctor

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guogang Luo, doctor

CONTACT

0086-13991974085; lguogang@163.com

Dan Zhu, master

CONTACT

0086-15229233307; 767441726@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)