Ticagrelor Therapy for RefrACTORy Migraine Study (NCT02518464) | Clinical Trial Compass
CompletedPhase 4
Ticagrelor Therapy for RefrACTORy Migraine Study
United States40 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.