Clopidogrel On Top of Aspirin For the Prevention of New Onset Migraine Headache Occurrence Following Transcatheter Closure of Atrial Septal Defects: A Prospective Randomized Trial (the CANOA Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.
研究概览
简要总结
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
详细描述
The objective is to evaluate the incidence and severity of new-onset migraine headache episodes following transcatheter ASD closure in patients treated with aspirin alone compared to those on aspirin + clopidogrel therapy as antithrombotic treatment after the procedure.
This is a prospective, randomized, double blind, multicenter study, including patients with no previous history of migraine attacks who have been diagnosed with an ASD and for whom transcatheter ASD closure has been clinically indicated. Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure. The occurrence and severity of migraine headaches will be evaluated by a neurologist using a structured headache questionnaire at 1 month and 3 months following ASD closure. An additional 6 month and 1 year follow-up evaluation will be exploratory according to local feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 year old undergoing transcatheter ASD closure with the Amplatzer Septal Occluder device (AGA medical Corp., MN, USA).
- •Female subjects must be post-menopausal, surgically sterile, or using an effective method of birth control.
- •Signed an informed consent document.
排除标准
- •Allergy or intolerance to any of the antithrombotic drugs (aspirin, clopidogrel) used in the study.
- •Need for anticoagulation therapy.
- •Use of ASD closure devices other than the Amplatzer Septal Occluder device.
- •History of migraine headaches (based on migraine headache questionnaire).
- •Refusal to sign the informed consent.
- •Pregnancy or breast-feeding or planning to become pregnant during the study.
- •Previous stroke.
研究组 & 干预措施
Aspirin + clopidogrel
Aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.
干预措施: Clopidogrel (Drug)
Aspirin
Aspirin (80 mg/day) for 3 months following ASD closure.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure.
时间窗: 3 months
次要结局
- Percentage of patients with new-onset migraine attacks.(3 months)
- Time to first migraine episode.(3 months)
- Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility).(1 year)
- Severity of migraine attacks following ASD closure as evaluated by the intensity of migraine episodes and the Migraine Disability Assessment (MIDAS) questionnaire at 3-month follow-up after ASD closure.(3 months)
- Incidence of bleeding complications at 3-month follow-up.(3 months)