Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

Phase 3

Recruiting

Interventions: Device: PFO closure device
Drug: Aspirin and clopidogrel
Drug: Triptans

Brief Summary: Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study

Recruitment & Eligibility

Inclusion Criteria

Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
Bubble study positive confirmed by transcranial doppler.
Subject is diagnosed of migraine.
Subject signs an informed Consent Form and is willing to participate in follow-up visits

Exclusion Criteria

Subject is diagnosed of headache with clear etiology.
Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
Brain CT/MR showed ischemic lesions.
Subject is diagnosed of hepatic insufficiency: ALT or AST>3×ULN at the screening visit.
Subject is diagnosed of moderate to severe renal insufficiency: eGFR<30ml/min/1.73m2 at the screening visit.
Subject has uncontrolled arrhythmia with clinical significance within 90 days.
Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
Subject cannot follow the study procedure due to other acute or chronic diseases.
Subject is pregnant or lactating.
Subject is under other RCT.
Subject has a life expectancy <1 year.
Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Serious Adverse Event (SAE) related due to device, drug or study procedure	Month 12	Primary Safety Endpoint
Complete cessation of migraine	Month 12	Primary Efficacy Endpoint

Secondary Outcome Measures

Name	Time	Method
Responder rate	Baseline and Month 12	Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline
Monthly migraine days	Baseline and Month 12	Mean change of monthly migraine days. Monthly migraine days = migraine attacks in one month × average time period per attacks (hours) /24 hours
Monthly migraine attacks	Baseline and Month 12	Mean change of monthly migraine attacks

Locations (20): The Eighth Affiliated Hospital, Sun Yat-sen University
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Guangzhou, Shenzhen, China
Huizhou First People's Hospital
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Huizhou, Guangdong, China
Jiangmen Central Hospital
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Jiangmen, Guangdong, China
Shenzhen People's Hospital
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Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
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Zhanjiang, Guangdong, China
The First People's Hospital of Nanning
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Nanning, Guangxi, China
Shangqiu First People's Hospital
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Shangqiu, Henan, China
Enshi Huiyi Hospital of Rheumatic Diseases
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Enshi, Hubei, China
Wuhan Asia Heart Hospital
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Wuhan, Hubei, China
Xiangya Hospital Central South University
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Changsha, Hunan, China
Zhongnan hospital of wuhan university
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Wuhan, Hubei, China
Nanjing First Hospital
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Nanjing, Jiangsu, China
China-Japan Friendship Hospital of Jilin University
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Changchun, Jilin, China
Tianjin Chest Hospital
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Tianjin, Tianjin, China
The people's hospital of Leshan
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Leshan, Sichuan, China
Xiamen Cardiovascular Hospital Xiamen University
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Xiamen, Fujian, China
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
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Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, China
Guangdong Sanjiu Brain Hospital
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Guangzhou, Guangdong, China
Shanxi Cardiovascular Hospital
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Taiyuan, Shanxi, China