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
DRUGAspirin 300mg
Aspirin 300 mg was administered once daily for 12 weeks.
DRUGMetoprolol 25mg
Metoprolol 25 mg was administered twice daily for 12 weeks.
DRUGClopidogrel 75mg
Clopidogrel 75 mg was administered once daily for 12 weeks.
DRUGRivaroxaban 20mg
Rivaroxaban 20 mg was administered once daily for 12 weeks.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Open-label treatment allocation with blinded outcome assessment based on prospectively completed headache diaries reviewed by independent neurologists blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria: 1. Aged 18 to 64 years at Visit 1. 2. Diagnosis of migraine with or without aura confirmed by a neurologist, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria. 3. History of migraine for more than 1 year, with an average of at least 4 migraine days per month during the 12-week screening period, as recorded in a headache diary and confirmed by the investigator at Visit 2. 4. Patent foramen ovale (PFO) diagnosed by transcranial Doppler (TCD), transthoracic echocardiography (TTE), or transesophageal echocardiography (TEE), with a right-to-left shunt at the atrial level. 5. Provision of written informed consent and willingness to comply with follow-up procedures.
Exclusion criteria
Participants will be excluded if any of the following apply: 1. Secondary headache attributable to other causes. 2. History of transient ischemic attack, stroke, or intracranial hemorrhage. 3. History of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure. 4. Right-to-left intracardiac shunt due to causes other than PFO. 5. Contraindications to antiplatelet or anticoagulant therapy, including thrombocytopenia, major trauma, active bleeding, decompensated cirrhosis, or drug allergy. 6. Contraindications to beta-blocker therapy, including hypotension, severe bradycardia, atrioventricular block, asthma, or drug allergy. 7. Poorly controlled atrial fibrillation at Visit 1. 8. Poorly controlled hypertension at Visit 1, defined as blood pressure \>160/90 mmHg despite regular medication. 9. Inability to maintain a headache diary or to reliably report headache symptoms. 10. Use of anticoagulants (e.g., warfarin, rivaroxaban) or antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor) within 12 weeks prior to Visit 2. 11. Use of metoprolol within 12 weeks prior to Visit 2. 12. Pregnancy, intention to become pregnant during the study period, or planned elective surgery during the study period. 13. Any condition that, in the investigator's opinion, may pose significant risk, confound study results, or interfere with participation. 14. Any other reasons (e.g., likely non-adherence, inability to attend follow-up visits, or planned relocation) that render the participant unsuitable for the study in the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | Baseline to 12 weeks post-randomization | Defined as the proportion of participants achieving a ≥50% reduction in the mean number of monthly migraine days or migraine attacks at 12 weeks post-randomization compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in monthly migraine days | Baseline to 12 weeks post-randomization | Change in the mean number of migraine days at 12 weeks post-randomization compared to baseline. |
| Change in monthly migraine attacks | Baseline to 12 weeks post-randomization | Change in the mean number of migraine attacks at 12 weeks post-randomization compared to baseline. |
| Reduction rate of migraine days | Baseline to 12 weeks post-randomization | Percentage reduction in the mean number of migraine days at 12 weeks post-randomization compared to baseline. |
| Reduction rate of migraine attacks | Baseline to 12 weeks post-randomization | Percentage reduction in the mean number of migraine attacks at 12 weeks post-randomization compared to baseline. |
| Complete migraine cessation | Weeks 9-12 post-randomization | Percentage of participants achieving complete migraine cessation during the 12-week treatment period. |
| Migraine-specific quality of life (MSQ v2.1) | Baseline to 12 weeks post-randomization | Change in Migraine-Specific Quality of Life Questionnaire (MSQ version 2.1) scores at 12 weeks post-randomization compared to baseline. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiangbin Pan
National Center for Cardiovascular Disease, China & Fuwai Hospital
Outcome results
None listed