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NCT05546320 | RECRUITING | Patent Foramen Ovale

Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale
Sponsor:

Chinese Academy of Medical Sciences, Fuwai Hospital

Information provided by (Responsible Party):

pan

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.

Condition or disease

Patent Foramen Ovale

Migraine

Intervention/treatment

Aspirin 100mg

Metoprolol 25 Mg Oral Tablet

Clopidogrel 75mg

Rivaroxaban 20mg

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 1000 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale
Actual Study Start Date : 2022-10-15
Estimated Primary Completion Date : 2024-06-01
Estimated Study Completion Date : 2025-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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%.
Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale

Location Details

NCT05546320

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How to Participate

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Locations

RECRUITING

China, Beijing

Fuwai Hospital

Beijing, Beijing, China,