CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Ticagrelor 90 mg twice per daydrug
Likely dose
Ticagrelor 90 mg twice per dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02518464
NCT02518464Phase 4Completed

Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)

Columbia University·interventional·Posted Aug 7, 2015·Updated Jun 4, 2019

In Brief

A Phase 4 clinical trial evaluating Ticagrelor 90 mg twice per day for Migraine and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 7, 2015
Enrollment StartOct 1, 2015
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.9 years ago

Interventions

Ticagrelor 90 mg twice per daydrug

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.