Ticagrelor Therapy for RefrACTORy Migraine Study

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: AstraZeneca
• Treatments: Adenosine; Ticagrelor

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