Ticagrelor Therapy for RefrACTORy Migraine Study

Completed · Phase 4

Conditions studied: Migraine, Headache, Migraine Headache

In brief

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.

Key facts

Study ID

NCT02518464

Run by

Columbia University

People needed

40

Starts

2015-10-01

Expected to finish

2017-10-01

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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