Ticagrelor Therapy for RefrACTORy Migraine Study
CompletedPhase 4NCT02518464
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)
- Interventions
- Drug: Ticagrelor 90 mg twice per day
- Sponsor
- Columbia University
- Collaborators
- AstraZeneca
- Start date
- 2015-10
- Primary completion
- 2017-10
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 the study time-frame * Previously implanted patent foramen ovale (PFO), atrial septal defect (ASD), pacemaker, inferior vena cava filter, or left atrial appendage closure device
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02518464