Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05546320
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale
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': 'D008790', 'term': 'Metoprolol'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], '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': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder rate', 'timeFrame': 'From baseline period to 3-month treatment period', 'description': 'Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.'}, {'measure': 'Treatment safety', 'timeFrame': 'From baseline period to 3-month treatment period', 'description': 'Adverse events after medication treatment'}], 'secondaryOutcomes': [{'measure': 'Migraine days change per month', 'timeFrame': 'From baseline period to 3-month treatment period', 'description': 'Change in the mean number of migraine days from baseline to treatment phase.'}, {'measure': 'Number of migraine attacks change per month', 'timeFrame': 'From baseline period to 3-month treatment period', 'description': 'Change in the mean number of migraine attacks from baseline to treatment phase.'}, {'measure': 'Percentage of migraine change', 'timeFrame': 'From baseline period to 3-month treatment period', 'description': 'Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Patent Foramen Ovale', 'Medication therapy'], 'conditions': ['Patent Foramen Ovale', 'Migraine']}, 'referencesModule': {'references': [{'pmid': '38109984', 'type': 'DERIVED', 'citation': 'Li Z, Dong J, Yan Y, Fang F, Wang C, Zhang F, Ouyang W, Wang S, Pan X. Study design and rationale of COMPETE: Comparison of the effect of medication therapy in alleviating migraine with patent foramen ovale. Am Heart J. 2024 Mar;269:1-7. doi: 10.1016/j.ahj.2023.12.011. Epub 2023 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 ；\n2. Diagnosed migraine by ICHD-3\n3. History of migraine longer than 1 year\n4. TCD/TTE/TEE diagnosed patent foramen ovale\n5. Willing to participant and agree to follow-ups\n\nExclusion Criteria:\n\n1. Migraine caused by other reason\n2. Had TIA/stroke history\n3. Hypersensitive or hyposensitive to the study drug\n4. With a history of anticoagulation or anti-platelet drug intake 3 month before randomization.\n5. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.'}, 'identificationModule': {'nctId': 'NCT05546320', 'acronym': 'COMPETE', 'briefTitle': 'Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale', 'orgStudyIdInfo': {'id': 'No2022-1758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Migraine Medication Group', 'description': 'Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group.', 'interventionNames': ['Drug: Metoprolol 25 Mg Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Anticoagulation or anti-platelet medication Group 1', 'description': 'Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin.', 'interventionNames': ['Drug: Aspirin 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'Anticoagulation or anti-platelet medication Group 2', 'description': 'Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel.', 'interventionNames': ['Drug: Clopidogrel 75mg']}, {'type': 'EXPERIMENTAL', 'label': 'Anticoagulation or anti-platelet medication Group 3', 'description': 'Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban.', 'interventionNames': ['Drug: Rivaroxaban 20mg']}], 'interventions': [{'name': 'Aspirin 100mg', 'type': 'DRUG', 'description': 'Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.', 'armGroupLabels': ['Anticoagulation or anti-platelet medication Group 1']}, {'name': 'Metoprolol 25 Mg Oral Tablet', 'type': 'DRUG', 'description': 'Metoprolol 25mg will be provided for the participants twice a day.', 'armGroupLabels': ['Migraine Medication Group']}, {'name': 'Clopidogrel 75mg', 'type': 'DRUG', 'description': 'Clopidogrel 75mg will be provided for the participant once a day.', 'armGroupLabels': ['Anticoagulation or anti-platelet medication Group 2']}, {'name': 'Rivaroxaban 20mg', 'type': 'DRUG', 'description': 'Rivaroxaban 20mg will be provided for the participant once a day.', 'armGroupLabels': ['Anticoagulation or anti-platelet medication Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangbin Pan, MD', 'role': 'CONTACT', 'email': 'panxiangbin@fuwaihospital.org', 'phone': '88396666'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiangbin Pan', 'role': 'CONTACT', 'email': 'panxiangbin@fuwaihospital.org', 'phone': '88396666'}, {'name': 'Fengwen Zhang', 'role': 'CONTACT', 'email': 'zhangfengwen08@126.com', 'phone': '88396666'}], 'overallOfficials': [{'name': 'Xiangbin Pan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager', 'investigatorFullName': 'Pan Xiangbin', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}