Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

Migraine Clinical Trial

— SPRING  

Official title:

Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine （SPRING）: a Multicenter, Random, Case Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946734
• Other study ID #: SPRING2021
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Migraine
• Migraine Disorders
• PFO - Patent Foramen Ovale

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