NCT03197194已完成3 期
A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 17
- 主要终点
- visual acuity (VA) improvement after treatment
研究概览
简要总结
The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.
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
- Double (Participant, 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 aged up to 18 years
- •CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist.
- •Blindness defined according to WHO classification as visual acuity <1/20 (20/400).
- •Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset.
- •No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis
- •No clinical or radiological evidence of stroke within the last 3 months.
- •Patients covered by health care insurance (social security)
- •Written informed consent obtained.
排除标准
- •Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset.
- •Minor VA deficit or VA rapidly improving before start of infusion.
- •CRAO without foveal ischemia.
- •Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy.
- •Clinical or laboratory evidence of temporal arteritis.
- •Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI.
- •Pregnant or lactating women
- •Adults under guardianship or trusteeship
- •Any contraindication to alteplase
- •Any contraindication to aspirin
研究组 & 干预措施
A : Alteplase
Experimental
Intravenous injection of Alteplase and one tablet of placebo
干预措施: Alteplase (Drug)
A : Alteplase
Experimental
Intravenous injection of Alteplase and one tablet of placebo
干预措施: Placebo Oral Tablet (Drug)
B : Acetylsalicylic Acid
Active Comparator
one tablet of Acetylsalicylic Acid and one dose of IV placebo
干预措施: acetylsalicylic acid (Drug)
B : Acetylsalicylic Acid
Active Comparator
one tablet of Acetylsalicylic Acid and one dose of IV placebo
干预措施: placebo IV (Drug)
结局指标
主要结局
visual acuity (VA) improvement after treatment
时间窗: 1 month
Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale
次要结局
- Time course of VA on ETDRS chart or ordinal scale(3 months)
- Quality of life related to vision (NEI-VFQ-25) after treatment(3 months)
- Time-to-treatment administration impact on VA evolution.(1 month)
- Global disability (modified Rankin scale) after treatment(3 months)
- Visual field(3 months)
- Tolerance(3 months)
- Proportion of blindness patients after treatment(1 month)
研究者
研究点 (17)
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