NCT04946734进行中（未招募）3 期
Effectivity and Safety of PFO Closure Vs Medicine in Alleviating Migraine （SPRING）: a Multicenter, Random, Case Control Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 20
- 主要终点
- Serious Adverse Event (SAE) related due to device, drug or study procedure
研究概览
简要总结
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
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
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
- •Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
- •Bubble study positive confirmed by transcranial doppler.
- •Subject is diagnosed of migraine.
- •Subject signs an informed Consent Form and is willing to participate in follow-up visits
排除标准
- •Subject is diagnosed of headache with clear etiology.
- •Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
- •Brain CT/MR showed ischemic lesions.
- •Subject is diagnosed of hepatic insufficiency: ALT or AST>3×ULN at the screening visit.
- •Subject is diagnosed of moderate to severe renal insufficiency: eGFR<30ml/min/1.73m2 at the screening visit.
- •Subject has uncontrolled arrhythmia with clinical significance within 90 days.
- •Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
- •Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
- •Subject cannot follow the study procedure due to other acute or chronic diseases.
- •Subject is pregnant or lactating.
- •Subject is under other RCT.
- •Subject has a life expectancy <1 year.
- •Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.
研究组 & 干预措施
Test Arm
Experimental
Device PFO closure
干预措施: PFO closure device (Device)
Test Arm
Experimental
Device PFO closure
干预措施: Aspirin and clopidogrel (Drug)
Test Arm
Experimental
Device PFO closure
干预措施: Triptans (Drug)
Control Arm
Other
Drugs only
干预措施: Aspirin and clopidogrel (Drug)
Control Arm
Other
Drugs only
干预措施: Triptans (Drug)
结局指标
主要结局
Serious Adverse Event (SAE) related due to device, drug or study procedure
时间窗: Month 12
Primary Safety Endpoint
Complete cessation of migraine
时间窗: Month 12
Primary Efficacy Endpoint
次要结局
- Responder rate(Baseline and Month 12)
- Monthly migraine days(Baseline and Month 12)
- Monthly migraine attacks(Baseline and Month 12)
研究者
Zhang Caojin, MD
Principal Investigator
Guangdong Provincial People's Hospital
研究点 (20)
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