Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE (AT-SUITABLE): a Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 824
- 试验地点
- 2
- 主要终点
- number of participants with aneurysm rupture or growth
研究概览
简要总结
The management of small unruptured intracranial aneurysms (UIA) with ischemic cerebrovascular disease (ICVD) has been a very controversial topic in neurosurgery. Thus, we initiated a multicenter, prospective, randomized controlled trial (PROBE) design to elucidate in UIA patients with ICVD who do not qualify for preventive endovascular or neurosurgical intervention whether aspirin treatment decreases the risk of aneurysm growth and rupture.
详细描述
Unruptured IAs are prevalent cerebrovascular disorders affecting approximately 3%-5% of the general population. The mortality rate associated with the rupture of UIAs stands at around 30%-40%, with over one-third of survivors experiencing significant neurological deficits. Currently, there are no established guidelines for the management of UIAs with ICVD. Our AIUIA trial is the inaugural randomized study investigating the potential of an anti-inflammatory strategy in mitigating aneurysm growth or rupture in patients with UIAs and ICVD who do not undergo preventive occlusion. It has the potential to provide level-A evidence that supports the aforementioned patient management approach.
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
blinded-endpoint, PROBE design
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged more than 18 and less than 80 years
- •patients with UIAs < 5 and ≥2 mm in the greatest diameter confirmed by MR angiography (MRA), computed tomography angiography (CTA) , or digital subtraction angiography (DSA)
- •patients with either symptomatic ICVD (ischemic stroke or transient ischemic attack) or asymptomatic ICVD (clinically silent lacunar infarction identified on brain CT/MR imaging)
- •last aneurysm imaging with either CTA or MRA or DSA within the last 3 months
- •ability of the subject to understand character and individual consequences of clinical trial
- •patients who provided written informed consent
- •patients who consented to follow-up imaging with the same MR angiography or CT angiography modality
排除标准
- •multiple aneurysms
- •a history of intracranial aneurysm rupture-related hemorrhage
- •a family history of intracranial aneurysm
- •a history of vascular malformation (brain arteriovenous malformation, moyamoya disease, arteriovenous fistula, etc.), brain tumor, hydrocephalus, or hypertensive cerebral hemorrhage etc.
- •MR contraindications (metallic implant, contrast medium allergy, claustrophobia, etc).
- •a precondition modified Rankin Scale (mRS) score > 2
- •fusiform or daughter sac UIAs
- •an allergy to aspirin
- •other contraindications for aspirin not yet mentioned, in the dosage of 100 mg/day (e.g. bleeding disorders, gastric or intestinal ulcers, acute liver failure or kidney failure, severe heart failure, treatment with methotrexate in a dosage 15 mg/week or above)
- •pregnancy and lactation
- •participation in another clinical trial or observation period of competing trials
- •residence in a rural area that prevented regular follow-up
- •poor compliance
研究组 & 干预措施
Aspirin
low-dose aspirin, 100 mg once daily, one 100mg tablet
干预措施: Aspirin Enteric-coated Tablets (Drug)
结局指标
主要结局
number of participants with aneurysm rupture or growth
时间窗: 24 months
primary composite outcome involving aneurysm growth ((1) ≥1.0mm in at least 1 direction by identical imaging modalities, (2) ≥0.5 mm in 2 directions by identical imaging modalities, and (3) an indisputable change in aneurysm shape) or rupture on repeated magnetic resonance- or CT-angiography within 24 months after randomization.
次要结局
- degree of C-reaction protein level change(24 months)
- degree of cytokines level change(24 months)
- any hemorrhagic stroke(24 months)
- any systematic bleeding(24 months)
- all cause mortality(24 months)
- number of participants with de novo aneurysm on repeated angiography(24 months)
- number of participants with aneurysm rupture(24 months)
- number of participants with aneurysm growth on repeated angiography(24 months)
- recurrent or new ischemic events(24 months)
- adverse events (AEs)/serious adverse events (SAEs)(24 months)
研究者
Dr. Yong Cao
deputy director
Beijing Tiantan Hospital