Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms
试验速览
- 阶段
- 3 期
- 入组人数
- 776
- 试验地点
- 14
- 主要终点
- aneurysm rupture or growth
研究概览
简要总结
Purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid (ASA) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below 120 mmHg), and a blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no ASA, blood pressure management according to standard blood pressure management, no blood pressure measuring device)
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
- Single (Outcomes Assessor)
盲法说明
observer blinding
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 years or older with an intradural, saccular unruptured aneurysm (UIA) in whom it is decided not to intervene with preventive endovascular or neurosurgical repair of the aneurysm and who are monitored on a regular base for aneurysm growth
- •Last aneurysm imaging with either CTA/MRA/DSA within the last 3 months
排除标准
- •All non-saccular UIAs or aneurysms related to arteriovenous malformations
- •Frequent ASA use and/or indication for a vitamin K antagonist, or direct oral anticoagulant (DOAC) treatment at baseline
- •Contra-indication for ASA
- •History of hypersensitivity to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
- •Chronic kidney disease stage IV and V (GFR < 30 mL/min/1.73 m2)
- •Pregnancy and lactation
- •Participation in another clinical trial or observation period of competing trials, respectively
- •Life-expectancy <3 years
研究组 & 干预措施
Acetylsalicylic acid, BP-target 120
100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
干预措施: Acetylsalicylic acid (Drug)
Acetylsalicylic acid, BP-target 120
100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
干预措施: intensive blood pressure control (Other)
结局指标
主要结局
aneurysm rupture or growth
时间窗: 36 months
aneurysm rupture (i.e. aneurysmal subarachnoid hemorrhage, SAH) or growth (increase in any aneurysm diameter by ≥1mm) on serial imaging (either two MR or CT angiographies)
次要结局
- therapy of aneurysm(36 months)
- new aneurysm(36 months)
- major bleeding(36 months)
- Incidence of Treatment-Emergent Adverse and Serious Adverse Events(36 months)
- aneurysm volume(36 months)
- death(36 months)
- stroke(36 months)
- myocard infarction(36 months)
- vascular death(36 months)
- achieved blood pressure(36 months)
研究者
Nima Etminan
Vice Chair
Universitätsmedizin Mannheim