Migraine Clinical Trial
— SPRINGOfficial title:
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine (SPRING): a Multicenter, Random, Case Control Study
Effectivity and safety of PFO closure vs medicine in alleviating migraine (SPRING): a multicenter, random, case control study
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial People's Hospital |
China,
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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