Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches
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|ClinicalTrials.gov Identifier: NCT02777359|
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : July 19, 2017
The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at embryonic stage, is closed normally at 5-7 months after birth. When it is not closed, it is referred to as the patent foramen ovale (PFO), which is found in approximately 1/4 of general population. It was shown in the studies in recent years that the risks of cryptogenic stroke, migraine, peripheral arterial embolism and decompression sickness in the patients with PFO were several times higher than those in healthy people. Therefore, PFO, previously considered a condition without the necessity of treatment, causes the attention of many experts and scholars around the world. Migraine with or without aura is defined as one of the most disabling chronic diseases, since according to WHO, the disability adjusted life year caused by migraine was second only to that by non-fatal stroke in 2005. In recent years, an increasing number of researches suggested that migraine is closely related to the right-to-left shunt (RLS) in the heart. And PFO is clinically considered as the most common cause of RLS.
The closure treatment for PFO-induced migraine has been gradually applied in several hospitals in China. The relationship of PFO with migraine, however, was not evaluated systematically based on specific standards, unfortunately leading to non-inclusion of many high-risk patients with PFO in the evaluation. The following aspects are to be fully recognized: the selecting and screening procedures for the high-risk population with PFO-induced migraine; the indications and standards of closure treatment for PFO in the patients with PFO-induced migraine; and the possibility that the made-in-China occluders substitute for those imported in the prevention from migraine. Furthermore, there is still a lack of prospective, multi-center, randomized and controlled studies in this subject, and standard or normal screening and treatment procedures have not yet been established in China. From this point, the investigators developed the Chinese people-specific procedures and standards of diagnosis of PFO-induced migraine in this study, based on current standards and methods of diagnosis, treatment and prevention of PFO-induced migraine in foreign countries. And the investigators prospectively adopted continuous inclusion of the high-risk patients with PFO-induced migraine, who were randomly divided into the closure treatment (transcatheter closure of PFO) group and the medication (drugs administered alone) group at the ratio of 1:1., in order to evaluate if the interventional treatment is better than the medication alone in these patients, to assess the efficacy and safety of the made-in-China occluders in the interventional treatment and prevention of PFO-induced migraine, and to identify the incidence of PFO in the patients with migraine in China and develop the Chinese people-specific screening protocols of PFO-induced migraine.
|Condition or disease||Intervention/treatment||Phase|
|Patent Foramen Ovale||Procedure: the transcatheter closure of PFO||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches:A Prospective,Multicenter,Randomized,Controlled Trial|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: the closure group
In the closure group, the transcatheter closure of PFO was performed using the made-in-China occluders approved by SFDA, in combination of clopidogrel(50mg/d, 3mon) and aspirin (0.1g/d, 6mon), i.e. oral administration of aspirin (0.1g/d) and clopidogrel (50mg/d) at 48h before the closure; the low molecular weight heparin (LMWH) was routinely given at 48h after the closure; and some pain-relief drugs could be temporarily administered in the patients with acute onset of migraine.
Procedure: the transcatheter closure of PFO
the transcatheter closure of PFO was performed using the made-in-China occluders approved by SFDA,clopidogrel(50mg/d, 3mon) , aspirin (0.1g/d, 6mon), i.e. oral administration of aspirin (0.1g/d) and clopidogrel (50mg/d) at 48h before the closure; the low molecular weight heparin (LMWH) was routinely given at 48h after the closure; and some pain-relief drugs could be temporarily administered in the patients with acute onset of migraine.
No Intervention: the medication group
In the medication group, in combination of clopidogrel (50mg/d, 3mon) and aspirin (0.1g/d, 6mon), current medication resumed, including conventional prescription for migraine as β-receptor blockers, calcium-ion antagonists, antiepileptics, antidepressants and non-steroid anti-inflammatory drugs (NSAID).
- migraine days after randomization [ Time Frame: up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777359
|Contact: Zhang Yu Shun, PHDfirstname.lastname@example.org|
|First Affiliated Hospital of Xian JiaotongUniversity||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Zhang Yu Shun, PHD 0086-029-85324625 email@example.com|
|Study Chair:||Zhang Yu Shun, PHD||First Affiliated Hospital of Xian JiaotongUniversity|