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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,000
Aspirin 300 mg was administered once daily for 12 weeks.
Metoprolol 25 mg was administered twice daily for 12 weeks.
Clopidogrel 75 mg was administered once daily for 12 weeks.
Rivaroxaban 20 mg was administered once daily for 12 weeks.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Suzhou Hospital of Anhui Medical University
Suzhou, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Responder rate
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.
Time frame: Baseline to 12 weeks post-randomization
Change in monthly migraine days
Change in the mean number of migraine days at 12 weeks post-randomization compared to baseline.
Time frame: Baseline to 12 weeks post-randomization
Change in monthly migraine attacks
Change in the mean number of migraine attacks at 12 weeks post-randomization compared to baseline.
Time frame: Baseline to 12 weeks post-randomization
Reduction rate of migraine days
Percentage reduction in the mean number of migraine days at 12 weeks post-randomization compared to baseline.
Time frame: Baseline to 12 weeks post-randomization
Reduction rate of migraine attacks
Percentage reduction in the mean number of migraine attacks at 12 weeks post-randomization compared to baseline.
Time frame: Baseline to 12 weeks post-randomization
Complete migraine cessation
Percentage of participants achieving complete migraine cessation during the 12-week treatment period.
Time frame: Weeks 9-12 post-randomization
Migraine-specific quality of life (MSQ v2.1)
Change in Migraine-Specific Quality of Life Questionnaire (MSQ version 2.1) scores at 12 weeks post-randomization compared to baseline.
Time frame: Baseline to 12 weeks post-randomization
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Gansu Provincial Hospital
Lanzhou, Gansu, China
The Second Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Shenzhen, Guangdong, China
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, China
...and 29 more locations