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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04946734
Other study ID # SPRING2021
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 12, 2021
Est. completion date July 1, 2025

Study information

Verified date December 2023
Source Guangdong Provincial People's Hospital
Contact Zhang Caojin, MD
Phone 83827812
Email yszcj74@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 440
Est. completion date July 1, 2025
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Device:
PFO closure device
Device PFO closure.
Drug:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete cessation of migraine Primary Efficacy Endpoint Month 12
Primary Serious Adverse Event (SAE) related due to device, drug or study procedure Primary Safety Endpoint Month 12
Secondary Monthly migraine attacks Mean change of monthly migraine attacks Baseline and Month 12
Secondary Monthly migraine days Mean change of monthly migraine days. Monthly migraine days = migraine attacks in one month × average time period per attacks (hours) /24 hours Baseline and Month 12
Secondary Responder rate Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline Baseline and Month 12
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