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

Korábbi kezelés

• Use of anticoagulants (e.g., warfarin, rivaroxaban) or antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor) within 12 weeks prior to Visit 2.
• Use of metoprolol within 12 weeks prior to Visit 2.
• Pregnancy, intention to become pregnant during the study period, or planned elective surgery during the study period.

Más betegség

• History of transient ischemic attack, stroke, or intracranial hemorrhage.
• History of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure.
• Contraindications to antiplatelet or anticoagulant therapy, including thrombocytopenia, major trauma, active bleeding, decompensated cirrhosis, or drug allergy.
• Contraindications to beta-blocker therapy, including hypotension, severe bradycardia, atrioventricular block, asthma, or drug allergy.
• Poorly controlled hypertension at Visit 1, defined as blood pressure >160/90 mmHg despite regular medication.
• Any condition that, in the investigator's opinion, may pose significant risk, confound study results, or interfere with participation.

Egyéb

• Participants will be excluded if any of the following apply:
• Secondary headache attributable to other causes.
• Right-to-left intracardiac shunt due to causes other than PFO.
• Poorly controlled atrial fibrillation at Visit 1.
• Inability to maintain a headache diary or to reliably report headache symptoms.
• 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.

• Participants must meet all of the following criteria:
• Aged 18 to 64 years at Visit 1.
• Diagnosis of migraine with or without aura confirmed by a neurologist, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
• 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.
• 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.
• Provision of written informed consent and willingness to comply with follow-up procedures.