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Medical Hypothesis
November 26, 2018

Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR)
An open-label pilot study

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Adam M. Reisman, BS, Barbara T. Robbins, FNP-BC, Denise E. Chou, MD, Marianna Shnayderman Yugrakh, MD, Giti J. Gross, FNP-BC, Lauren Privitera, MS, MPH, Tamim Nazif, MD, and Robert J. Sommer, MDAuthors Info & Affiliations
November 27, 2018 issue
91 (22) 1010-1017
https://doi.org/10.1212/WNL.0000000000006573
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Abstract

Objective

After finding that the thienopyridines clopidogrel and prasugrel reduced migraine headache (MHA) symptoms in some patients with patent foramen ovale (PFO), this small pilot study was undertaken to determine whether ticagrelor, a nonthienopyridine P2Y12 inhibitor, would have similar MHA effects and might be better suited for a future randomized trial.

Methods

MHA patients were screened for PFO. Participants with documented right to left shunt (RLS) and ≥6 monthly MHA days received ticagrelor therapy for 28 days. Those with ≥50% reduction in monthly MHA days were deemed responders and completed 2 additional treatment months.

Results

The 40 participants had a mean age of 36.2 years and mean MHA frequency of 17.4 d/mo. A total of 39/40 were female. A total of 14/40 met criteria for episodic MHA, 26/40 for chronic MHA, 14/40 had migraine with aura, and 22/40 had a moderate–large RLS (Spencer grade ≥4). Seventeen of 40 participants (43%) were responders. MHA reduction continued through 3 treatment months in all responders. MHA responder rates were not statistically different in participants with episodic or chronic MHA, with or without aura, or with small/larger RLS shunt magnitude. Thirteen (32%) patients had medication side effects, without serious adverse events.

Conclusion

P2Y12 inhibition with ticagrelor reduced MHA symptoms similarly to our previous thienopyridine experience, but participants seemed to have a less robust MHA benefit and more frequent side effects than with the thienopyridines, making it an inferior choice for a randomized trial.

Classification of evidence

This study provides Class IV evidence that ticagrelor reduced MHA symptoms in patients with PFO.

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Publication history

Received by Neurology February 2, 2018. Accepted in final form July 18, 2018.

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Information & Authors

Information

Published In

Neurology®
Volume 91 • Number 22 • November 27, 2018
Pages: 1010-1017
PubMed: 30478067

Copyright

© 2018 American Academy of Neurology.

Publication History

Received: February 2, 2018
Accepted: July 18, 2018
Published online: November 26, 2018
Published in issue: November 27, 2018

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Disclosure

A. Reisman reports no disclosures relevant to the manuscript. B. Robbins participates in a monthly physician training course for Abbott Medical (Amplatzer PFO closure device), which may or may not be interpreted as a conflict of interest. D. Chou reports the following corporate relationships, which may or may not be considered a conflict of interest: she is currently a full-time employee of Amgen but was a full-time employee at Columbia University Medical Center at the time of study participation; participates in advisory boards for Amgen, Teva, Eli Lilly, Allergan, and Pernix; is PI for clinical trials sponsored by Cefaly Technology, Teva, Alder, and Capnia; and received honorarium from GammaCore as well as speaking honoraria from Medscape and Peerview (funded by an educational grant from Teva). M. Shnayderman Yugrakh reports that she is a PI for clinical trials sponsored by Teva and Cefaly Technology. G. Gross, L. Privitera, and T. Nazif report no disclosures relevant to the manuscript. R. Sommer reports the following corporate relationships, which may or may not be considered a conflict of interest relative to this research: applied and was awarded an investigator-initiated grant provided by AstraZeneca and was approved for the off-label use of ticagrelor through an IDE with the FDA (125,532) for the TRACTOR Migraine Trial; is developing a National Migraine/PFO Protocol based on this manuscript with WL Gore and Associates; was a PI on the REDUCE PFO/Stroke Trial (WL Gore and Associates); was the National PI on the ESCAPE Migraine PFO Trial (St. Jude Medical); is the Co-National PI for the ASSURED ASD Closure Trial (WL Gore and Associates); is a physician trainer for Abbott Medical (Amplatzer PFO closure device); and is a physician trainer for Boston Scientific (Watchman Device). Go to Neurology.org/N for full disclosures.

Study Funding

The TRACTOR study was fully funded by an investigator-initiated grant provided by AstraZeneca (ClinicalTrials.gov NCT02518464, FDA IDE 125,532).

Authors

Affiliations & Disclosures

Adam M. Reisman, BS
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Barbara T. Robbins, FNP-BC
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
Participate in a monthly physician training course for Abbott Medical (Amplatzer PFO closure device) as a Columbia University Medical Center employee, which may or may not be interpreted as a conflict of interest.
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Denise E. Chou, MD
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
(1) Served on advisory boards for Amgen, Teva, Eli Lilly, Allergan, and Pernix
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Cefaly Technology, travel honoraria to present prior work at a conference (2) GammaCore, travel honoraria
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Currently employed at Amgen Position: Global Medical Director Date of Hire: October 16, 2017
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
Speaker honoraria from Peerview, Medscape, and AAN for CME activities
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1) Cefaly Technology (2) Teva (3) Alder (4) Capnia Stock/Stock Options, Medical Equipment & Materials: I currently own stock options in Amgen, where I am a full- time employee as of October 16, 2017.
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Marianna Shnayderman Yugrakh, MD
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Teva Pharmaceutical Cefaly Technology
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Giti J. Gross, FNP-BC
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Lauren Privitera, MS, MPH
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Tamim Nazif, MD
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
(1) Cardiovascular Research Foundation (CRF), data safety monitoring boards and clinical events committees
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Structural Heart Journal, associate editor, 2017 to present
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
(1) Edwards LifeSciences, (2) Medtronic, (3) Boston Scientific, (4) BioTrace Medical
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Robert J. Sommer, MD
From the Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve Center (A.M.R., B.T.R., L.P., T.N., R.J.S.) and Headache Center, Department of Neurology (D.E.C., M.S.Y., G.J.G.), New York–Presbyterian Hospital/Columbia University Medical Center, NY.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
WL Gore & Associates: Consulting in the development of a National PFO/Migraine Trial WL Gore & Associates: National Co-PI on ASSURED ASD Trial
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
Abbott Medical: Physician Training/Proctorship Boston Scientific: Physician Training/Proctorship AstraZeneca: Investigator Initiated Grant for the TRACTOR Trial Migraine Trial using Ticagrelor
Clinical Procedures or Imaging Studies:
1.
I close up to 200 PFO's a year primarily in patients with cryptogenic stroke and do consultations on these patients in the office. The migraine population is a small fraction of my practice at Columbia University Medical Center (New York, NY).
Research Support, Commercial Entities:
1.
AstraZeneca: Investigator Initiated Grant for the TRACTOR Migraine Trial using Ticagrelor (this paper)
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
2 years ago, converted/sold Stock Options from Coherex Medical in the amount of $8000 (primarily animal device implantation)
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
I have been consulted as an expert in reviewing several malpractice cases (some involving PFO) over the past two years.
View all articles by this author

Notes

Correspondence Dr. Sommer [email protected]
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

Author Contributions

Adam M. Reisman directed the data collection, consented all of the patients, and wrote the initial draft of the manuscript. Barbara T. Robbins helped to collect all of the study follow-up data, performed the initial interpretation of the trial data, and helped recruit patients for the trial. Denise E. Chou helped to develop the neurologic aspects of the protocol and reviewed the manuscript for content and scientific merit. Marianna Shnayderman Yugrakh helped to develop the neurologic aspects of the protocol and reviewed the manuscript for content and scientific merit. Giti J. Gross helped recruit patients for the study and collect initial patient data. Lauren Privitera was instrumental in helping to develop the protocol and in working with the IRB. Tamim Nazif helped design the trial and critically reviewed the manuscript for style, content, and scientific merit. Robert J. Sommer conceived of the study design, interacted with the study sponsor, recruited patients for the study, and was the editor/author on the final manuscript.

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