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Completed

NCT Number: NCT02518464

Ticagrelor Therapy for RefrACTORy Migraine Study

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.

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Key information

Conditions

Migraine Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Graft vs Host Disease Headache Headache Disorders Headache Disorders, Primary Immune System Diseases Lung Diseases Lung Diseases, Obstructive Migraine Disorders Migraine Headache Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

Migraine headaches are poorly understood, and can be severely debilitating. Many types of drugs have been tried in migraine sufferers including anti-depressants, anti-seizure medications, blood pressure medicines and others. The investigators have shown that in a small number of patients, a certain type of blood thinner (Clopidogrel) can reduce or eliminate migraine headaches in patients who also have a hole in the heart wall that allows flow from the right side of the heart to the left. Ticagrelor is a blood thinning drug which works in the same way as the clopidogrel, but is broken down by the body differently and thus allows everyone to use it. The investigators wish to test this medication to see if it works as well, or better than the clopidogrel.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 90 mg twice per day

Drug

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.

Other names: Brilinta

Primary outcomes

  1. Total Number of Responders

    Time frame: 1 month from baseline

    A participant will be considered to have achieved the primary efficacy endpoint (a "Responder") if she/he has >50% reduction in the number of monthly headache days during the month of therapy compared with participant's own baseline. If there is < 50% reduction in the number of migraine days, she/he will be considered a Non-Responder.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)

Acronym: TRACTOR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2015
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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