Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR)
An open-label pilot study
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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.
Glossary
- DSMB=
- data safety monitoring board;
- ICHD=
- International Classification of Headache Disorders;
- MHA=
- migraine headache;
- MSQ=
- Migraine-Specific Quality of Life Questionnaire;
- PFO=
- patent foramen ovale;
- RLS=
- right to left shunt;
- TCD=
- transcranial Doppler;
- TRACTOR=
- Ticagrelor for Refractory Migraine/Patent Foramen Ovale
Footnotes
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.
Class of Evidence: NPub.org/coe
Editorial page 993
See page 1002
- Received February 2, 2018.
- Accepted in final form July 18, 2018.
- © 2018 American Academy of Neurology
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