TY - JOUR
T1 - Ticagrelor for refractory migraine/patent foramen ovale (TRACTOR)
T2 - An open-label pilot study
AU - Reisman, Adam M.
AU - Robbins, Barbara T.
AU - Chou, Denise E.
AU - Yugrakh, Marianna Shnayderman
AU - Gross, Giti J.
AU - Privitera, Lauren
AU - Nazif, Tamim
AU - Sommer, Robert J.
N1 - Funding Information:
The TRACTOR study was fully funded by an investigator-initiated grant provided by AstraZeneca (ClinicalTrials.gov NCT02518464, FDA IDE 125,532).
Funding Information:
The Ticagrelor for Refractory Migraine/Patent Foramen Ovale (TRACTOR) Pilot Trial was funded through an investigator-initiated grant by AstraZeneca PLC (Clin-icalTrials.gov NCT02518464), received an investigational device exemption (IDE) from the Food and Drug Administration (125,532) and was reviewed and approved by the Institutional Review Board at Columbia University Medical Center (Protocol AAAO4109). Study oversight was provided by a data safety monitoring board (DSMB), consisting of both cardiologists and neurologists at Columbia University Medical Center.
Publisher Copyright:
Copyright © 2018 American Academy of Neurology.
PY - 2018
Y1 - 2018
N2 - 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.MHAreduction 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.
AB - 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.MHAreduction 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.
UR - http://www.scopus.com/inward/record.url?scp=85057241027&partnerID=8YFLogxK
U2 - 10.1212/WNL.0000000000006573
DO - 10.1212/WNL.0000000000006573
M3 - Article
C2 - 30478067
AN - SCOPUS:85057241027
SN - 0028-3878
VL - 91
SP - 1010
EP - 1017
JO - Neurology
JF - Neurology
IS - 22
ER -