Ticagrelor Therapy for RefrACTORy Migraine Study
Condition: Migraine; Headache; Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Ticagrelor 90 mg twice per day
Intervention description: Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: headache; chronic; migraine; right to left shunt

Summary:

      This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the
      hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg
      by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in
      patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be
      compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy
      was effective (> 50% reduction in monthly headache days), the subject could elect to continue
      therapy for an additional two months (56 days), while continuing to complete daily headache
      logs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least one year history of Episodic or Chronic migraine headache symptoms

          -  At least 6 headache days per month

          -  Subject able to complete online daily headache log

        Exclusion Criteria:

          -  Inability to understand the study or history of non-compliance with medical advice

          -  Currently taking a P2Y12 inhibitor

          -  Known hypersensitivity to Brilinta/ticagrelor

          -  History of stroke/transient ischemic attack (TIA) in the previous 6 months

          -  Active bleeding from any site

          -  Active peptic ulcer disease or upper gastrointestinal (GI) bleeding within six (6)
             months

          -  Migraine onset after 50 years of age

          -  Renal impairment: Creatinine Clearance < 60 cc/min

          -  Severe hepatic impairment with total bilirubin > 3.0 mg/dL

          -  Thrombocytopenia with platelet count < 100,000 / ul

          -  History of intracranial hemorrhage

          -  Contraindications to blood thinner therapy or history of major bleeding episode while
             taking blood thinner therapy

          -  Need for chronic oral anti-coagulation therapy (i.e. Atrial Fibrillation)

          -  Need for chronic anti-platelet therapy (i.e. drug-eluting (DE) Stent), including daily
             aspirin use

          -  Need for daily nonsteroidal anti-inflammatory drug (NSAID) use

          -  Need for daily carbamazepine therapy or other strong CYP3A inhibitors or potent CYP3A
             inducers

          -  Need for simvastatin or lovastatin greater than 40 mg daily

          -  Symptomatic bradycardia or syncope

          -  Pregnancy or currently breast-feeding, or plan to become pregnant during the study
             period

          -  Planned surgery during the study time-frame

          -  Previously implanted patent foramen ovale (PFO), atrial septal defect (ASD),
             pacemaker, inferior vena cava filter, or left atrial appendage closure device