CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
patent foramen ovale closuredevice
Likely dose
Not stated in record
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Search/NCT03521193
NCT03521193N/ACompleted

Migraine in Patients Undergoing PFO (Patent Foramen Ovale) Closure: Evaluation of a Platelet-associated Pathophysiologic Linking Mechanism

Centro Cardiologico Monzino·interventional·Posted May 11, 2018·Updated Apr 19, 2024

In Brief

A clinical study evaluating patent foramen ovale closure for Platelet Aggregation, Spontaneous and 2 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Migraine is a common, chronic neurovascular disorder characterized by attacks of severe headache, autonomic nervous system dysfunction and, in some patients, aura, and disabling neurological symptoms. Worldwide, migraine prevalence is as high as 18% in the general population. Increased frequency of patent foramen ovale (PFO) in migraineurs was first reported in 1998 in a case-control study. Since then, others have described a 60% prevalence of PFO in patients suffering from migraine with aura. The presence of a right-to-left shunt (RLS) is thought to be a potent trigger of migraine attacks, although the mechanism is unknown. Moreover, PFO closure has correlated with improved migraine symptoms in several retrospective uncontrolled studies. The aim of this single-center, prospective study is to assess the impact of PFO closure on migraine attacks over time together with evaluation of potential predictive risk factors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 11, 2018
Enrollment StartFeb 15, 2018
Primary CompletionOct 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.1 years ago

Interventions

patent foramen ovale closuredevice

Pts undergoing PFO closure will receive 2-months of DAPT and 6 months of aspirin after patent foramen ovale (PFO) closure; they will be compared to healthy subjects on aspirin treatment