Patent Foramen Ovale, Migraine
Conditions
Keywords
Migraine, Patent Foramen Ovale, Medication therapy
Brief summary
Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.
Interventions
DRUGClopidogrel 75mg
Clopidogrel 75mg will be provided for the participant once a day.
DRUGMetoprolol 25 Mg Oral Tablet
Metoprolol 25mg will be provided for the participants twice a day.
DRUGAspirin 100mg
Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.
DRUGRivaroxaban 20mg
Rivaroxaban 20mg will be provided for the participant once a day.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 ； 2. Diagnosed migraine by ICHD-3 3. History of migraine longer than 1 year 4. TCD/TTE/TEE diagnosed patent foramen ovale 5. Willing to participant and agree to follow-ups
Exclusion criteria
1. Migraine caused by other reason 2. Had TIA/stroke history 3. Hypersensitive or hyposensitive to the study drug 4. With a history of anticoagulation or anti-platelet drug intake 3 month before randomization. 5. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | From baseline period to 3-month treatment period | Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase. |
| Treatment safety | From baseline period to 3-month treatment period | Adverse events after medication treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine days change per month | From baseline period to 3-month treatment period | Change in the mean number of migraine days from baseline to treatment phase. |
| Number of migraine attacks change per month | From baseline period to 3-month treatment period | Change in the mean number of migraine attacks from baseline to treatment phase. |
| Percentage of migraine change | From baseline period to 3-month treatment period | Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase. |
Countries
China
Contacts
Primary ContactXiangbin Pan
Backup ContactFengwen Zhang
Outcome results
None listed