[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638428":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":40,"locations":48,"responsibleParty":66,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":32,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":100,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A - Thienopyridine only","ACTIVE_COMPARATOR","16 patients will be randomized to this group. Thienopyridine medication (prasugrel) which was demonstrated to reduce headache frequency during study screening phases, will be continued for 6 months and then stopped. Post-therapy headache frequency will be compared with the patient's baseline headache frequency. After completion of the study procedures, patients in this group will be given the opportunity to get the PFO closure procedure.",[13],"Drug: Prasugrel 5mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B - PFO closure plus thienopyridine","16 patients will be randomized to this group. After demonstrating thienopyridine (prasugrel) benefit for migraine symptoms in the screening phases of the study, patients in this arm will undergo PFO closure, a non-surgical outpatient catheter procedure. They will remain on prasugrel for an additional 6 months. The medication will then be stopped. Post-therapy headache frequency will be compared with the patient's baseline headache frequency.",[13,18],"Device: Transcatheter Closure of Patent Foramen Ovale",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Prasugrel 5mg","Six months of daily prasugrel therapy following randomization.",[9,15],[26],"Prasugrel Hydrochloride",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Transcatheter Closure of Patent Foramen Ovale","A standard transcatheter closure of PFO will be performed in the Group B cohort. During this non-surgical procedure, the GORE Cardioform Septal Occluder will be used to close the PFO (it is FDA-approved for exactly this purpose for prevention of recurrent stroke) but will be used here in an off-label fashion.",[15],null,[34,38],{"name":35,"affiliation":36,"role":37},"Jessica Ailani, MD","MedStar Georgetown University Hospital","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Robert J Sommer, MD",[41,45],{"name":39,"role":42,"phone":43,"phoneExt":32,"email":44},"CONTACT","212-342-0886","rs2463@cumc.columbia.edu",{"name":46,"role":42,"phone":43,"phoneExt":32,"email":47},"Barbara T Robbins, FNP-BC","bs2575@cumc.columbia.edu",[49],{"facility":50,"status":32,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Columbia University Medical Center","New York","10032","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-74.00597,40.71427,{"lat":59,"lon":58},[62,64,65],{"name":39,"role":42,"phone":63,"phoneExt":32,"email":44},"2123420886",{"name":46,"role":42,"phone":63,"phoneExt":32,"email":47},{"name":39,"role":37,"phone":32,"phoneExt":32,"email":32},{"type":37,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Robert Sommer","Associate Professor of Medicine; Director of Invasive Adult Congenital Heart Disease",[70,73],{"name":71,"class":72},"Occlutech International AB","INDUSTRY",{"name":74,"class":72},"W.L.Gore & Associates","100638428","phase-3-migraine-headaches-elimination-with-patent-foramen-ovale-directed-therapy-100638428",false,"NCT07629635","Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy","Cessation of Migraine Headaches With Patent Foramen Ovale-Directed Therapy (COMFORT - PFO): An Investigator-Initiated Study","COMFORT-PFO","Patient Inclusion Criteria:\n\n* Age: ≥18 and \\\u003C55 at time of screening\n* Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)\n* Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \\\u003C 40 years of age\n* By history, an average headache burden of greater than one migraine headache day per week:\n* without current preventative therapy, OR\n* despite preventative therapy, OR\n* with reason to come off effective therapy (e.g. cost, aversion to injections, side effects)\n* If patient is taking preventive migraine medications, dose must be stable for at least 3 months prior to the screening visit. Patient agrees to continue preventive medication at the current dosage throughout the duration of the Baseline and On-treatment monitoring periods (Study Weeks 1 - 17).\n* Female patients capable of becoming pregnant agree to use two forms of birth control or abstinence during their participation in the study.\n\nPatient Exclusion Criteria:\n\nExclusions due to underlying patient medical issues:\n\n* Headache disorder other than migraine with aura, or migraine without aura\n* Patient has history of stroke, TIA, or intracranial hemorrhage.\n* Patient has a history of thrombocytopenia within one year, or platelet count \\\u003C100,000\u002Fmm3 identified during the screening laboratory evaluation.\n* Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT\u002FPTT, or with total bilirubin \\>3.0 mg\u002FdL identified during the screening laboratory evaluation.\n* Patient has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, or left atrial appendage closure device or any cardiac history which, in the investigator's opinion, would preclude them from study participation.\n* Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.\n* Patient has a history of clinically significant bleeding within 6 months of the screening visit, any active bleeding, or active peptic ulcer disease.\n* Patient has an uncontrolled arrhythmia, or if on therapy, has evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia or atrial fibrillation while under rhythm control).\n* Patient has elevated PVR which in the opinion of the implanting physician precludes safe PFO closure.\n* Patient has active infection at the time of screening that cannot be treated.\n* Patient is planning surgery during the study timeframe.\n* A female patient is pregnant or is planning pregnancy during the anticipated duration of the study. Urine or blood pregnancy screening will be performed as part of the screening laboratory evaluation.\n* Patient has documented nickel allergy\u002Fsensitivity\n* Patient has a documented history of non-compliance with medical care, which would preclude them, in the opinion of the study team\n\nExclusion Due to Medication Restrictions:\n\n* Patient has known hypersensitivity or contraindication to thienopyridines\n* Patient has another medical condition requiring chronic antithrombotic therapy with antiplatelet, oral anticoagulant or injectable agents\n* Patient has need for daily use of NSAIDs other than for treatment of migraines","ALL","18 Years","55 Years",{"count":87,"type":88},32,"ESTIMATED","INTERVENTIONAL",[91],"PHASE3","Migraine is a common and often disabling condition, but its exact causes are not fully understood. Some people with migraines have a small opening in the heart wall called a patent foramen ovale (PFO). In some of these patients, closing this opening or taking a medication that inhibits blood platelets (prasugrel) has been shown to reduce migraines. However, not everyone benefits, and it is unclear why. This study is being done to better understand whether closing a PFO can provide lasting migraine relief - especially in patients whose migraines improve with prasugrel.\n\nThe goal of this study is to find out whether, in patients whose migraines improve while taking prasugrel, closing the PFO along with 24 weeks of prasugrel leads to better long-term migraine relief after stopping the medication, than by taking prasugrel for 24 weeks alone.\n\nParticipants will track their migraines daily using an electronic diary, then take prasugrel and compare their migraines while on the medication. Only patients whose migraines improve on this medication will continue in the study. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: 1) Medication-only group: Continue prasugrel for 24 weeks. 2) Procedure group: Undergo a minimally invasive procedure to close the PFO and continue prasugrel for 24 weeks. After treatment, the medication will be stopped in both groups, and participants will again track their migraines for about 8 weeks.\n\nThe main question is: Do patients who have PFO closure continue to have fewer migraines after stopping prasugrel compared with those who did not have the procedure?",[94,95],"Migraine Disease","Patent Foramen Ovale",[97,95,98,81,99],"Migraine Headaches","Thienopyridine","Prasugrel","NOT_YET_RECRUITING","2026-06-01",{"date":103,"type":104},"2026-06-05","ACTUAL",{"date":106,"type":88},"2026-09-01",{"date":108,"type":88},"2028-03",{"name":5,"class":6},1]