Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale (NCT05546320) | Clinical Trial Compass
CompletedPhase 2
Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale
China1,000 participantsStarted 2022-10-15
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. Secondary headache attributable to other causes.
✕. History of transient ischemic attack, stroke, or intracranial hemorrhage.
✕. History of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure.
What they're measuring
1
Responder rate
Timeframe: Baseline to 12 weeks post-randomization
Trial details
NCT IDNCT05546320
SponsorChinese Academy of Medical Sciences, Fuwai Hospital
✕. Right-to-left intracardiac shunt due to causes other than PFO.
✕. 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 atrial fibrillation at Visit 1.
✕. Poorly controlled hypertension at Visit 1, defined as blood pressure \>160/90 mmHg despite regular medication.