PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial sponsored by Columbia University, comparing two strategies for migraines in patients with a PFO. Participants who respond to prasugrel will be randomized to receive transcatheter PFO closure plus continued prasugrel or continued prasugrel alone, with follow-up to see if benefits persist after stopping the medication. The study uses daily electronic migraine diaries to track outcomes and includes adults aged 18 to 54 with migraine with or without aura. Eligibility requires a history of migraine for at least one year and a certain level of headache burden, with stable preventive therapy if applicable. The primary aim is to determine if PFO closure sustains migraine relief longer term when compared to medical therapy alone.

Why it matters

Who can join: the full rules

Patient Inclusion Criteria:

* Age: ≥18 and \<55 at time of screening
* Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)
* Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \< 40 years of age
* By history, an average headache burden of greater than one migraine headache day per week:
* without current preventative therapy, OR
* despite preventative therapy, OR
* with reason to come off effective therapy (e.g. cost, aversion to injections, side effects)
* 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).
* Female patients capable of becoming pregnant agree to use two forms of birth control or abstinence during their participation in the study.

Patient Exclusion Criteria:

Exclusions due to underlying patient medical issues:

* Headache disorder other than migraine with aura, or migraine without aura
* Patient has history of stroke, TIA, or intracranial hemorrhage.
* Patient has a history of thrombocytopenia within one year, or platelet count \<100,000/mm3 identified during the screening laboratory evaluation.
* Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT/PTT, or with total bilirubin \>3.0 mg/dL identified during the screening laboratory evaluation.
* 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.
* Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.
* Patient has a history of clinically significant bleeding within 6 months of the screening visit, any active bleeding, or active peptic ulcer disease.
* 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).
* Patient has elevated PVR which in the opinion of the implanting physician precludes safe PFO closure.
* Patient has active infection at the time of screening that cannot be treated.
* Patient is planning surgery during the study timeframe.
* 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.
* Patient has documented nickel allergy/sensitivity
* Patient has a documented history of non-compliance with medical care, which would preclude them, in the opinion of the study team

Exclusion Due to Medication Restrictions:

* Patient has known hypersensitivity or contraindication to thienopyridines
* Patient has another medical condition requiring chronic antithrombotic therapy with antiplatelet, oral anticoagulant or injectable agents
* Patient has need for daily use of NSAIDs other than for treatment of migraines

Where it's running

• Columbia University Irving Medical Center - NewYork Presbyterian Hospital (CUIMC/NYP)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jessica Ailani, MD — MedStar Georgetown University Hospital
• Study coordinator: Robert J Sommer, MD
• Email: rs2463@cumc.columbia.edu
• Phone: 212-342-0886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes after PFO closure at Severance Hospital

  This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.

  Recruiting Yonsei University · Seoul · NCT07724171

• P3 Occluder System for closing a heart opening (PFO) after stroke

  We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.

  Recruiting Recross Cardio, Inc. · Belgrade · NCT07698951

• Gepants for Acute Migraine in the Emergency Department

  This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.

  Recruiting Phase 1 University of South Florida · Tampa, Florida · NCT07667621

• Comparing Cocoon vs Amplatzer PFO Occluders in Adults After Stroke or TIA

  This trial tests whether the Cocoon PFO Occluder works as well as the Amplatzer PFO Occluder in adults who had a cryptogenic stroke or TIA and have a PFO requiring closure.

  Recruiting Sahajanand Medical Technologies Limited · Bad Oeynhausen, North Rhine-Westphalia (Nordrhein-Westfalen) · NCT07380490

• Neuropsychological and cognitive profile in adults with migraine

  This project will test how thinking skills and psychological factors (like anxiety, depression, worry, and coping) relate to migraine in adults who have had migraine for at least one year.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07233941

• Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

  This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

  Recruiting at 5 sites Recross Cardio, Inc. · Los Angeles, California and 4 other locations · NCT07172464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.