MigrainePhase 4NCT02938182
Migraine Prophylaxis With Clopidogrel Trial
A Phase 4 study testing clopidogrel in people with Migraine, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other types of headaches
- systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
- history of head injury
- other contraindications to clopidogrel treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Guogang Luo, doctor, 0086-13991974085, lguogang@163.com
Dan Zhu, master, 0086-15229233307, 767441726@qq.com
About this study
Official title: A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- clopidogrel
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called plavix
clopidogrel troche 75 mg daily for three months
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel | Experimental | clopidogrel tablet 75mg daily for three months Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Attack Duration of Headache at three months, h
Measured: three months
Secondary outcomes (4)
Change from Baseline Headache Frequency per Month at three months, time
Measured: three months
Change from Baseline Visual Analogue Scale at three months, scores
Measured: three months
Change from Baseline Migraine Disability Assessment Scale at three months, scores
Measured: three months
Change from Baseline Headache Impact Test at three months, scores
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guogang Luo, doctor, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938182
- Sponsor's protocol ID
- XJTU1AF-CRS-2016-019
- Status last verified
- Aug 2021
- First submitted
- 17 Oct 2016
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The information of the patients need to keep confidential.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
- ClinicalTrials.gov ID
- NCT02938182
- Acronym / sponsor ID
- XJTU1AF-CRS-2016-019
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | Experimental | Drug: clopidogrelclopidogrel tablet 75mg daily for three months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- other types of headaches
- systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
- history of head injury
- other contraindications to clopidogrel treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelAlso: plavixclopidogrel troche 75 mg daily for three months | Drug | clopidogrel |
Primary outcome
Change from Baseline Attack Duration of Headache at three months, h
Time frame: three months
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No. The information of the patients need to keep confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guogang Luo, doctor principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel in people with Migraine, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guogang Luo, doctor (0086-13991974085, lguogang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Attack Duration of Headache at three months, h (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.