Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
SPRING
1 other identifier
interventional
440
1 country
21
Brief Summary
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2021
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedStudy Start
First participant enrolled
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2025
CompletedMarch 12, 2025
March 1, 2025
4.1 years
June 23, 2021
March 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Complete cessation of migraine
Primary Efficacy Endpoint
Month 12
Serious Adverse Event (SAE) related due to device, drug or study procedure
Primary Safety Endpoint
Month 12
Secondary Outcomes (3)
Monthly migraine attacks
Baseline and Month 12
Monthly migraine days
Baseline and Month 12
Responder rate
Baseline and Month 12
Study Arms (2)
Test Arm
EXPERIMENTALDevice PFO closure
Control Arm
OTHERDrugs only
Interventions
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
If migraine recurred, Triptans would be administered during the acute phase.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361016, China
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Guangdong Sanjiu Brain Hospital
Guangzhou, Guangdong, 510510, China
The Eighth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Huizhou First People's Hospital
Huizhou, Guangdong, 516003, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
The First People's Hospital of Nanning
Nanning, Guangxi, 530022, China
Shangqiu First People's Hospital
Shangqiu, Henan, 476100, China
Enshi Huiyi Hospital of Rheumatic Diseases
Enshi, Hubei, 445099, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Zhongnan hospital of wuhan university
Wuhan, Hubei, 430071, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
China-Japan Friendship Hospital of Jilin University
Changchun, Jilin, 130033, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024, China
The Eighth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Shenzhen, 518033, China
The people's hospital of Leshan
Leshan, Sichuan, 614099, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
Related Publications (1)
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.
PMID: 38580946DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 23, 2021
First Posted
July 1, 2021
Study Start
August 12, 2021
Primary Completion
September 6, 2025
Study Completion
September 6, 2025
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
The deidentified participant data will be shared on a request basis.