Migraine Clinical Trial
Official title:
Clopidogrel On Top of Aspirin For the Prevention of New Onset Migraine Headache Occurrence Following Transcatheter Closure of Atrial Septal Defects: A Prospective Randomized Trial (the CANOA Study)
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
The objective is to evaluate the incidence and severity of new-onset migraine headache
episodes following transcatheter ASD closure in patients treated with aspirin alone compared
to those on aspirin + clopidogrel therapy as antithrombotic treatment after the procedure.
This is a prospective, randomized, double blind, multicenter study, including patients with
no previous history of migraine attacks who have been diagnosed with an ASD and for whom
transcatheter ASD closure has been clinically indicated. Patients will be randomized either
to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months
following ASD closure. The occurrence and severity of migraine headaches will be evaluated by
a neurologist using a structured headache questionnaire at 1 month and 3 months following ASD
closure. An additional 6 month and 1 year follow-up evaluation will be exploratory according
to local feasibility.
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