COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 39
- 主要终点
- Responder rate
研究概览
简要总结
Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open-label treatment allocation with blinded outcome assessment based on prospectively completed headache diaries reviewed by independent neurologists blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Aged 18 to 64 years at Visit
- •Diagnosis of migraine with or without aura confirmed by a neurologist, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
- •History of migraine for more than 1 year, with an average of at least 4 migraine days per month during the 12-week screening period, as recorded in a headache diary and confirmed by the investigator at Visit
- •Patent foramen ovale (PFO) diagnosed by transcranial Doppler (TCD), transthoracic echocardiography (TTE), or transesophageal echocardiography (TEE), with a right-to-left shunt at the atrial level.
- •Provision of written informed consent and willingness to comply with follow-up procedures.
排除标准
- •Participants will be excluded if any of the following apply:
- •Secondary headache attributable to other causes.
- •History of transient ischemic attack, stroke, or intracranial hemorrhage.
- •History of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure.
- •Right-to-left intracardiac shunt due to causes other than PFO.
- •Contraindications to antiplatelet or anticoagulant therapy, including thrombocytopenia, major trauma, active bleeding, decompensated cirrhosis, or drug allergy.
- •Contraindications to beta-blocker therapy, including hypotension, severe bradycardia, atrioventricular block, asthma, or drug allergy.
- •Poorly controlled atrial fibrillation at Visit
- •Poorly controlled hypertension at Visit 1, defined as blood pressure >160/90 mmHg despite regular medication.
- •Inability to maintain a headache diary or to reliably report headache symptoms.
- •Use of anticoagulants (e.g., warfarin, rivaroxaban) or antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor) within 12 weeks prior to Visit
- •Use of metoprolol within 12 weeks prior to Visit
- •Pregnancy, intention to become pregnant during the study period, or planned elective surgery during the study period.
- •Any condition that, in the investigator's opinion, may pose significant risk, confound study results, or interfere with participation.
- •Any other reasons (e.g., likely non-adherence, inability to attend follow-up visits, or planned relocation) that render the participant unsuitable for the study in the investigator's judgment.
研究组 & 干预措施
Migraine Medication Group - Metoprolol Group
Participants randomized to the active comparator group received metoprolol 25 mg orally twice daily for 12 weeks.
干预措施: Metoprolol 25mg (Drug)
Anticoagulation or anti-platelet medication Group 1 - Aspirin Group
Participants randomized to this group received aspirin 300 mg orally once daily for 12 weeks.
干预措施: Aspirin 300mg (Drug)
Anticoagulation or anti-platelet medication Group 2 - Clopidogrel Group
Participants randomized to this group received clopidogrel 75 mg orally once daily for 12 weeks.
干预措施: Clopidogrel 75mg (Drug)
Anticoagulation or anti-platelet medication Group 3 - Rivaroxaban Group
Participants randomized to this group received rivaroxaban 20 mg orally once daily for 12 weeks.
干预措施: Rivaroxaban 20mg (Drug)
结局指标
主要结局
Responder rate
时间窗: From baseline period to 3-month treatment period
Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
Treatment safety
时间窗: From baseline period to 3-month treatment period
Adverse events after medication treatment
Responder rate
时间窗: Baseline to 12 weeks post-randomization
Defined as the proportion of participants achieving a ≥50% reduction in the mean number of monthly migraine days or migraine attacks at 12 weeks post-randomization compared to baseline.
次要结局
- Migraine days change per month(From baseline period to 3-month treatment period)
- Number of migraine attacks change per month(From baseline period to 3-month treatment period)
- Percentage of migraine change(From baseline period to 3-month treatment period)
- Change in monthly migraine days(Baseline to 12 weeks post-randomization)
- Change in monthly migraine attacks(Baseline to 12 weeks post-randomization)
- Reduction rate of migraine days(Baseline to 12 weeks post-randomization)
- Reduction rate of migraine attacks(Baseline to 12 weeks post-randomization)
- Complete migraine cessation(Weeks 9-12 post-randomization)
- Migraine-specific quality of life (MSQ v2.1)(Baseline to 12 weeks post-randomization)
研究者
Pan Xiangbin
Project Manager
Chinese Academy of Medical Sciences, Fuwai Hospital