Clinical trial NCT04946734: Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
Official title: Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine （SPRING）: a Multicenter, Random, Case Control Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: PFO - Patent Foramen Ovale
Migraine
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 440
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Complete cessation of migraine
timeFrame: Month 12
measure: Serious Adverse Event (SAE) related due to device, drug or study procedure
timeFrame: Month 12
Secondary outcomes:
measure: Monthly migraine attacks
timeFrame: Baseline and Month 12
measure: Monthly migraine days
timeFrame: Baseline and Month 12
measure: Responder rate
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Sanjiu Brain Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Eighth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou First People's Hospital
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Nanning
country: China
facility: The First People's Hospital of Nanning
state: Guangxi
city: Shangqiu
country: China
facility: Shangqiu First People's Hospital
state: Henan
city: Enshi
country: China
facility: Enshi Huiyi Hospital of Rheumatic Diseases
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan hospital of wuhan university
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Friendship Hospital of Jilin University
state: Jilin
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Guangzhou
country: China
facility: The Eighth Affiliated Hospital, Sun Yat-sen University
state: Shenzhen
city: Leshan
country: China
facility: The people's hospital of Leshan
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
References: