Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine (SPRING)

December 16, 2023 updated by: Zhang Caojin, MD, Guangdong Provincial People's Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361016
        • Recruiting
        • Xiamen Cardiovascular Hospital Xiamen University
        • Contact:
          • Chen Weibin, M.D.
        • Principal Investigator:
          • Chen Weibin, M.D.
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Guo Tao, M.D.
        • Principal Investigator:
          • Guo Tao, M.D.
        • Sub-Investigator:
          • Cui Tongtao, M.D.
      • Guangzhou, Guangdong, China, 510510
        • Recruiting
        • Guangdong Sanjiu Brain Hospital
        • Contact:
          • Wang Zhanhang, M.D.
        • Principal Investigator:
          • Wang Zhanhang, M.D.
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
        • Contact:
          • Zhang Caojin, MD
        • Principal Investigator:
          • Zhang Caojin, M.D.
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Eighth Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Xiong Zhaojun, M.D.
        • Principal Investigator:
          • Xiong Zhaojun, M.D.
      • Huizhou, Guangdong, China, 516003
        • Recruiting
        • Huizhou First People's Hospital
        • Contact:
          • Gao Hanhua, M.D.
        • Principal Investigator:
          • Gao Hanhua, M.D.
      • Jiangmen, Guangdong, China, 529000
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
          • Lai Junxing, M.D.
        • Principal Investigator:
          • Lai Junxing, M.D.
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
          • Yuan Jie, M.D.
        • Principal Investigator:
          • Yuan Jie, M.D.
      • Zhanjiang, Guangdong, China, 524001
        • Recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Chen Jianying, M.D.
        • Principal Investigator:
          • Chen Jianying, M.D.
    • Guangxi
      • Nanning, Guangxi, China, 530022
        • Recruiting
        • The First People's Hospital of Nanning
        • Contact:
          • Wang Xiaodong, M.D.
        • Principal Investigator:
          • Wang Xiaodong, M.D.
    • Henan
      • Shangqiu, Henan, China, 476100
        • Recruiting
        • Shangqiu First People's Hospital
        • Contact:
          • Liu Wei, M.D.
        • Principal Investigator:
          • Liu Wei, M.D.
    • Hubei
      • Enshi, Hubei, China, 445099
        • Recruiting
        • Enshi Huiyi Hospital of Rheumatic Diseases
        • Contact:
          • Zhang Hongwei, M.D.
        • Principal Investigator:
          • Zhang Hongwei, M.D.
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Zhang Gangcheng, M.D.
        • Principal Investigator:
          • Zhang Zhang, M.D.
        • Sub-Investigator:
          • Zheng Xuan, M.D.
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
          • Shen Qunshan, M.D.
        • Principal Investigator:
          • Shen Qunshan, M.D.
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Chen Xiaobin, M.D.
        • Principal Investigator:
          • Chen Xiaobin, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Contact:
          • Xie Dujiang, M.D.
        • Principal Investigator:
          • Xie Dujiang, M.D.
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recruiting
        • China-Japan friendship Hospital of Jilin university
        • Contact:
          • Zhang Wenqi, M.D.
        • Principal Investigator:
          • Zhang Wenqi, M.D.
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Recruiting
        • Shanxi Cardiovascular Hospital
        • Contact:
          • Wang Zhongchao, M.D.
        • Principal Investigator:
          • Wang Zhongchao, M.D.
    • Shenzhen
      • Guangzhou, Shenzhen, China, 518033
        • Recruiting
        • The Eighth Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Wei Wenbin, M.D.
        • Principal Investigator:
          • Wei Wenbin, M.D.
    • Sichuan
      • Leshan, Sichuan, China, 614099
        • Recruiting
        • The people's hospital of Leshan
        • Contact:
          • Zhou Yang, M.D.
        • Principal Investigator:
          • Zhou Yang, M.D.
    • Tianjin
      • Tianjin, Tianjin, China, 300222
        • Recruiting
        • Tianjin Chest Hospital
        • Contact:
          • Zhang Wei, M.D.
        • Principal Investigator:
          • Zhang Wei, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Arm
Device PFO closure
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.
Drug: Triptans
If migraine recurred, Triptans would be administered during the acute phase.
Other: Control Arm
Drugs only
Drug: Aspirin and clopidogrel
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
Drug: Triptans
If migraine recurred, Triptans would be administered during the acute phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete cessation of migraine
Time Frame: Month 12
Primary Efficacy Endpoint
Month 12
Serious Adverse Event (SAE) related due to device, drug or study procedure
Time Frame: Month 12
Primary Safety Endpoint
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly migraine attacks
Time Frame: Baseline and Month 12
Mean change of monthly migraine attacks
Baseline and Month 12
Monthly migraine days
Time Frame: Baseline and Month 12
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
Responder rate
Time Frame: Baseline and Month 12
Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline
Baseline and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRING2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The deidentified participant data will be shared on a request basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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