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Migraine Prophylaxis With Clopidogrel Trial

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ClinicalTrials.gov Identifier: NCT02938182
Recruitment Status : Unknown
Verified October 2016 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Change from Baseline Attack Duration of Headache at three months, h [ Time Frame: three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Change from Baseline Headache Frequency per Month at three months, time [ Time Frame: three months ]
  • Change from Baseline Visual Analogue Scale at three months, scores [ Time Frame: three months ]
  • Change from Baseline Migraine Disability Assessment Scale at three months, scores [ Time Frame: three months ]
  • Change from Baseline Headache Impact Test at three months, scores [ Time Frame: three months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Migraine Prophylaxis With Clopidogrel Trial
Official Title  ICMJE A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: clopidogrel
clopidogrel troche 75 mg daily for three months
Other Name: plavix
Study Arms  ICMJE Experimental: clopidogrel
clopidogrel tablet 75mg daily for three months
Intervention: Drug: clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938182
Other Study ID Numbers  ICMJE XJTU1AF-CRS-2016-019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The information of the patients need to keep confidential.
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor  ICMJE First Affiliated Hospital Xi'an Jiaotong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guogang Luo, doctor First Affiliated Hospital Xi'an Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP