Ticagrelor Therapy for RefrACTORy Migraine Study (TRACTOR)

June 3, 2019 updated by: Robert Sommer, Columbia University

Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Brilinta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Robert J Sommer, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAO4109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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