Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total Number of Responders
研究概览
简要总结
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.
详细描述
Migraine headaches are poorly understood, and can be severely debilitating. Many types of drugs have been tried in migraine sufferers including anti-depressants, anti-seizure medications, blood pressure medicines and others. The investigators have shown that in a small number of patients, a certain type of blood thinner (Clopidogrel) can reduce or eliminate migraine headaches in patients who also have a hole in the heart wall that allows flow from the right side of the heart to the left. Ticagrelor is a blood thinning drug which works in the same way as the clopidogrel, but is broken down by the body differently and thus allows everyone to use it. The investigators wish to test this medication to see if it works as well, or better than the clopidogrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ticagrelor 90 mg twice per day
Interventions include the following: All participants will have a loading dose of Ticagrelor (Brilinta) 180 mg administered in the office at the time of enrollment. Thereafter, for 28 days, Ticagrelor 90 mg tablet will be taken once in the morning and once in the evening, as close to 12 hours apart as possible. Each day, the subject will receive a text message reminder to login to the website, to record her/his headache activity.
干预措施: Ticagrelor 90 mg twice per day (Drug)
结局指标
主要结局
Total Number of Responders
时间窗: 1 month from baseline
A participant will be considered to have achieved the primary efficacy endpoint (a "Responder") if she/he has \>50% reduction in the number of monthly headache days during the month of therapy compared with participant's own baseline. If there is \< 50% reduction in the number of migraine days, she/he will be considered a Non-Responder.
次要结局
未报告次要终点
研究者
Robert Sommer
Assistant Professor of Clinical Medicine
Columbia University