Back to resultsEffectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine (SPRING)
Primary Purpose
PFO - Patent Foramen Ovale, Migraine
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PFO closure device
Aspirin and clopidogrel
Triptans
Sponsored by
About this trial
This is an interventional treatment trial for PFO - Patent Foramen Ovale
Eligibility Criteria
Inclusion Criteria:
- Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
- Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
- Bubble study positive confirmed by transcranial doppler.
- Subject is diagnosed of migraine.
- Subject signs an informed Consent Form and is willing to participate in follow-up visits
Exclusion Criteria:
- Subject is diagnosed of headache with clear etiology.
- Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
- Brain CT/MR showed ischemic lesions.
- Subject is diagnosed of hepatic insufficiency: ALT or AST>3×ULN at the screening visit.
- Subject is diagnosed of moderate to severe renal insufficiency: eGFR<30ml/min/1.73m2 at the screening visit.
- Subject has uncontrolled arrhythmia with clinical significance within 90 days.
- Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
- Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
- Subject cannot follow the study procedure due to other acute or chronic diseases.
- Subject is pregnant or lactating.
- Subject is under other RCT.
- Subject has a life expectancy <1 year.
- Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.
Sites / Locations
- Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Test Arm
Control Arm
Arm Description
Device PFO closure
Drugs only
Outcomes
Primary Outcome Measures
Complete cessation of migraine
Primary Efficacy Endpoint
Serious Adverse Event (SAE) related due to device, drug or study procedure
Primary Safety Endpoint
Secondary Outcome Measures
Monthly migraine attacks
Mean change of monthly migraine attacks
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
Responder rate
Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline
Full Information
NCT ID
NCT04946734
First Posted
June 23, 2021
Last Updated
July 5, 2021
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04946734
Brief Title
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
Acronym
SPRING
Official Title
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine （SPRING）: a Multicenter, Random, Case Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2021 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PFO - Patent Foramen Ovale, Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Arm
Arm Type
Experimental
Arm Description
Device PFO closure
Arm Title
Control Arm
Arm Type
Other
Arm Description
Drugs only
Intervention Type
Device
Intervention Name(s)
PFO closure device
Intervention Description
Device PFO closure.
Intervention Type
Drug
Intervention Name(s)
Aspirin and clopidogrel
Intervention Description
Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
Intervention Type
Drug
Intervention Name(s)
Triptans
Intervention Description
If migraine recurred, Triptans would be administered during the acute phase.
Primary Outcome Measure Information:
Title
Complete cessation of migraine
Description
Primary Efficacy Endpoint
Time Frame
Month 12
Title
Serious Adverse Event (SAE) related due to device, drug or study procedure
Description
Primary Safety Endpoint
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Monthly migraine attacks
Description
Mean change of monthly migraine attacks
Time Frame
Baseline and Month 12
Title
Monthly migraine days
Description
Mean change of monthly migraine days. Monthly migraine days = migraine attacks in one month × average time period per attacks (hours) /24 hours
Time Frame
Baseline and Month 12
Title
Responder rate
Description
Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline
Time Frame
Baseline and Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
Bubble study positive confirmed by transcranial doppler.
Subject is diagnosed of migraine.
Subject signs an informed Consent Form and is willing to participate in follow-up visits
Exclusion Criteria:
Subject is diagnosed of headache with clear etiology.
Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
Brain CT/MR showed ischemic lesions.
Subject is diagnosed of hepatic insufficiency: ALT or AST>3×ULN at the screening visit.
Subject is diagnosed of moderate to severe renal insufficiency: eGFR<30ml/min/1.73m2 at the screening visit.
Subject has uncontrolled arrhythmia with clinical significance within 90 days.
Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
Subject cannot follow the study procedure due to other acute or chronic diseases.
Subject is pregnant or lactating.
Subject is under other RCT.
Subject has a life expectancy <1 year.
Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Caojin, MD
Phone
83827812
Email
yszcj74@163.com
Facility Information:
Facility Name
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Caojin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The deidentified participant data will be shared on a request basis.
Learn more about this trial
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
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