Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
NCT ID: NCT04946734
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2021-08-12
2025-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Arm
Device PFO closure
PFO closure device
Device PFO closure.
Aspirin and clopidogrel
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
Triptans
If migraine recurred, Triptans would be administered during the acute phase.
Control Arm
Drugs only
Aspirin and clopidogrel
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
Triptans
If migraine recurred, Triptans would be administered during the acute phase.
Interventions
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PFO closure device
Device PFO closure.
Aspirin and clopidogrel
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
Triptans
If migraine recurred, Triptans would be administered during the acute phase.
Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
60 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Zhang Caojin, MD
Principal Investigator
Locations
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Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Sanjiu Brain Hospital
Guangzhou, Guangdong, China
The Eighth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Huizhou First People's Hospital
Huizhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
The First People's Hospital of Nanning
Nanning, Guangxi, China
Shangqiu First People's Hospital
Shangqiu, Henan, China
Enshi Huiyi Hospital of Rheumatic Diseases
Enshi, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Zhongnan hospital of wuhan university
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
China-Japan Friendship Hospital of Jilin University
Changchun, Jilin, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
The Eighth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Shenzhen, China
The people's hospital of Leshan
Leshan, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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Zi-Yang Y, Hezhi L, Dongling L, Ximeng W, Caojin Z; SPRING Investigators. Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail. BMC Cardiovasc Disord. 2024 Apr 5;24(1):198. doi: 10.1186/s12872-024-03866-3.
Other Identifiers
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SPRING2021
Identifier Type: -
Identifier Source: org_study_id
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