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Active, not recruiting Phase 3

Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

NCT04946734 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2021-08-12
Last updated
2025-03-12

Condition(s) studied

PFO - Patent Foramen OvaleMigraine

Investigational drug(s) / intervention(s)

PFO closure deviceAspirin and clopidogrel →Triptans →

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.

Study summary

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

Eligibility

Sex
ALL
Min age
16 Years
Max age
60 Years
Healthy volunteers
No
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 outcome measure(s)

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

Trial sites (21)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04946734 on ClinicalTrials.gov ↗ ← All trials in China