Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 10:34 PM
Study NCT ID:
NCT04946734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D014363', 'term': 'Tryptamines'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete cessation of migraine', 'timeFrame': 'Month 12', 'description': 'Primary Efficacy Endpoint'}, {'measure': 'Serious Adverse Event (SAE) related due to device, drug or study procedure', 'timeFrame': 'Month 12', 'description': 'Primary Safety Endpoint'}], 'secondaryOutcomes': [{'measure': 'Monthly migraine attacks', 'timeFrame': 'Baseline and Month 12', 'description': 'Mean change of monthly migraine attacks'}, {'measure': 'Monthly migraine days', 'timeFrame': 'Baseline and Month 12', 'description': 'Mean change of monthly migraine days. Monthly migraine days = migraine attacks in one month × average time period per attacks (hours) /24 hours'}, {'measure': 'Responder rate', 'timeFrame': 'Baseline and Month 12', 'description': 'Percentage of subject with at least 50% reduction in monthly migraine attacks from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PFO - Patent Foramen Ovale', 'Migraine']}, 'referencesModule': {'references': [{'pmid': '38580946', 'type': 'DERIVED', 'citation': 'Zi-Yang Y, Hezhi L, Dongling L, Ximeng W, Caojin Z; SPRING Investigators. Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail. BMC Cardiovasc Disord. 2024 Apr 5;24(1):198. doi: 10.1186/s12872-024-03866-3.'}]}, 'descriptionModule': {'briefSummary': 'Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Presence of PFO with right-to-left shunt, confirmed by Transthoracic.\n2. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.\n3. Bubble study positive confirmed by transcranial doppler.\n4. Subject is diagnosed of migraine.\n5. Subject signs an informed Consent Form and is willing to participate in follow-up visits\n\nExclusion Criteria:\n\n1. Subject is diagnosed of headache with clear etiology.\n2. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.\n3. Brain CT/MR showed ischemic lesions.\n4. Subject is diagnosed of hepatic insufficiency: ALT or AST\\>3×ULN at the screening visit.\n5. Subject is diagnosed of moderate to severe renal insufficiency: eGFR\\<30ml/min/1.73m2 at the screening visit.\n6. Subject has uncontrolled arrhythmia with clinical significance within 90 days.\n7. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.\n8. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.\n9. Subject cannot follow the study procedure due to other acute or chronic diseases.\n10. Subject is pregnant or lactating.\n11. Subject is under other RCT.\n12. Subject has a life expectancy \\<1 year.\n13. Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.'}, 'identificationModule': {'nctId': 'NCT04946734', 'acronym': 'SPRING', 'briefTitle': 'Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine （SPRING）: a Multicenter, Random, Case Control Study', 'orgStudyIdInfo': {'id': 'SPRING2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Arm', 'description': 'Device PFO closure', 'interventionNames': ['Device: PFO closure device', 'Drug: Aspirin and clopidogrel', 'Drug: Triptans']}, {'type': 'OTHER', 'label': 'Control Arm', 'description': 'Drugs only', 'interventionNames': ['Drug: Aspirin and clopidogrel', 'Drug: Triptans']}], 'interventions': [{'name': 'PFO closure device', 'type': 'DEVICE', 'description': 'Device PFO closure.', 'armGroupLabels': ['Test Arm']}, {'name': 'Aspirin and clopidogrel', 'type': 'DRUG', 'description': 'Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.', 'armGroupLabels': ['Control Arm', 'Test Arm']}, {'name': 'Triptans', 'type': 'DRUG', 'description': 'If migraine recurred, Triptans would be administered during the acute phase.', 'armGroupLabels': ['Control Arm', 'Test Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361016', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Xiamen Cardiovascular Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510510', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Sanjiu Brain Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Eighth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '516003', 'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Huizhou First People's Hospital", 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}, {'zip': '529000', 'city': 'Jiangmen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Jiangmen Central Hospital', 'geoPoint': {'lat': 22.58333, 'lon': 113.08333}}, {'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '524001', 'city': 'Zhanjiang', 'state': 'Guangdong', 'country': 'China', 'facility': 'Affiliated Hospital of Guangdong Medical University', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '530022', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': "The First People's Hospital of Nanning", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '476100', 'city': 'Shangqiu', 'state': 'Henan', 'country': 'China', 'facility': "Shangqiu First People's Hospital", 'geoPoint': {'lat': 34.45, 'lon': 115.65}}, {'zip': '445099', 'city': 'Enshi', 'state': 'Hubei', 'country': 'China', 'facility': 'Enshi Huiyi Hospital of Rheumatic Diseases', 'geoPoint': {'lat': 30.3, 'lon': 109.48333}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan hospital of wuhan university', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '130033', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'China-Japan Friendship Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '030024', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Cardiovascular Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '518033', 'city': 'Guangzhou', 'state': 'Shenzhen', 'country': 'China', 'facility': 'The Eighth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '614099', 'city': 'Leshan', 'state': 'Sichuan', 'country': 'China', 'facility': "The people's hospital of Leshan", 'geoPoint': {'lat': 29.56227, 'lon': 103.76386}}, {'zip': '300222', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The deidentified participant data will be shared on a request basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhang Caojin, MD', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}