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Ticagrelor Therapy for RefrACTORy Migraine Study (TRACTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02518464
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Information provided by (Responsible Party):
Robert Sommer, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Headache Migraine Headache Drug: Ticagrelor 90 mg twice per day Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: Ticagrelor 90 mg twice per day
Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.
Drug: Ticagrelor 90 mg twice per day
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 Name: Brilinta

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02518464

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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Principal Investigator: Robert J Sommer, MD Columbia University
  Study Documents (Full-Text)

Documents provided by Robert Sommer, Columbia University:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert Sommer, Assistant Professor of Clinical Medicine, Columbia University Identifier: NCT02518464    
Other Study ID Numbers: AAAO4109
First Posted: August 7, 2015    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Sommer, Columbia University:
right to left shunt
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs