Comparing medication therapies for migraines in patients with a heart condition
COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale
PHASE4 · Chinese Academy of Medical Sciences, Fuwai Hospital · NCT05546320
This study is testing different migraine medications, including blood thinners, to see which ones work best for people with a heart condition called patent foramen ovale (PFO).
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05546320 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of different medication therapies, including anticoagulation and anti-platelet treatments, in alleviating migraine symptoms in patients diagnosed with patent foramen ovale (PFO). It aims to compare these therapies against conventional migraine medications to determine which approach offers better relief and reduces the frequency of migraine attacks. The study will involve multiple centers and will enroll participants aged 18 to 65 who have a history of migraines and a confirmed diagnosis of PFO. By analyzing the outcomes, the trial seeks to provide clinical guidance for treating migraines in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a diagnosed history of migraines and confirmed patent foramen ovale.
Not a fit: Patients whose migraines are caused by other reasons or who have a history of stroke or transient ischemic attack may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for migraine patients with PFO, improving their quality of life.
How similar studies have performed: Previous observational studies have suggested potential benefits of anticoagulation and anti-platelet therapies for migraines in patients with PFO, but this approach is being formally tested for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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%.
Where this trial is running
Beijing, Beijing
- Fuwai Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Xiangbin Pan — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Xiangbin Pan
- Email: panxiangbin@fuwaihospital.org
- Phone: 88396666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patent Foramen Ovale, Migraine, Medication therapy