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Ticagrelor Therapy for RefrACTORy Migraine Study (TRACTOR)

Primary Purpose

Migraine, Headache, Migraine Headache

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ticagrelor 90 mg twice per day
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring headache, chronic, migraine, right to left shunt

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ticagrelor 90 mg twice per day

Arm Description

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.

Outcomes

Primary Outcome Measures

Total Number of Responders
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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
June 3, 2019
Sponsor
Columbia University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02518464
Brief Title
Ticagrelor Therapy for RefrACTORy Migraine Study
Acronym
TRACTOR
Official Title
Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache, Migraine Headache
Keywords
headache, chronic, migraine, right to left shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor 90 mg twice per day
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90 mg twice per day
Other Intervention Name(s)
Brilinta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Number of Responders
Description
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.
Time Frame
1 month from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Sommer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30478067
Citation
Reisman AM, Robbins BT, Chou DE, Yugrakh MS, Gross GJ, Privitera L, Nazif T, Sommer RJ. Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR): An open-label pilot study. Neurology. 2018 Nov 27;91(22):1010-1017. doi: 10.1212/WNL.0000000000006573.
Results Reference
derived

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Ticagrelor Therapy for RefrACTORy Migraine Study

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