NCT05941377已完成不适用
Randomized Controlled Trial of Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2023年8月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- UIA instability
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA).
The main questions it aims to answer are:
- To provide high-level evidence of the benefits and safety of controlled hypotension in patients with UIA.
- To provide evidence-based medical evidence for blood pressure control of patients with UIA in neurosurgery, and promote the progress of accurate individual management of patients. In this study, the main intervention is enhanced blood pressure lowering in patients with UIA.
All Patients will be randomly assigned to either the standard blood pressure lowering (SBPL) group or the enhanced blood pressure lowering (EBPL) group.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese ethnicity.
- •Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.
- •Maximal size of UIA at largest dimension < 7 mm
- •The morphology of UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/ multi-lobular UIA fundus)
- •UIA receiving conservative treatment
- •History of primary hypertension (as diagnosed per standard of care)
- •Systolic blood pressure (SBP) on 2 consecutive visits:
- •SBP: 130-180 mmHg on 0 or 1 antihypertensive medication. SBP: 130-170 mmHg on up to 2 antihypertensive medications. SBP: 130-160 mmHg on up to 3 antihypertensive medications. SBP: 130-150 mmHg on up to 4 antihypertensive medications
- •Good medication adherence (Morisky Medication Adherence Scale ≥6)
- •Obtain informed consent from patient or legal representative
排除标准
- •Patients with neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on.
- •Patients with additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc.
- •Patients with fusiform, dissecting, blister, traumatic, mycotic/ bacterial, myxomatous, and tumor-associated UIAs are excluded.
- •Patients with history of polycystic kidney disease, rheumatic disease or autoimmune disease.
- •Patients with family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage).
- •Patients with known secondary cause of hypertension.
- •Patients with myocardial infarction, ischemic stroke, symptomatic heart failure during the past 3 months.
- •Patients with a medical condition likely to limit survival to less than 2 years.
- •Patients during pregnancy and perinatal period.
- •Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
- •Inability or unwillingness of patient or legal representative to give written informed consent.
- •Participation in a concurrent interventional medical investigation or clinical trial.
研究组 & 干预措施
enhanced blood pressure lowering (EBPL) group
Experimental
干预措施: blood pressure lowering (Other)
standard blood pressure lowering (SBPL) group
Experimental
干预措施: blood pressure lowering (Other)
结局指标
主要结局
UIA instability
时间窗: 24 months
The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms \[sentinel headache and oculomotor paralysis\]).
safety endpoint
时间窗: 24 months
The safety endpoint is any ischemic cerebral or cardiac events. This includes one or more of the following: new or more frequent transient ischemic attack, new clinical or radiological ischemic stroke, angina, new myocardial infarction, or reperfusion therapy for myocardial infarction.
次要结局
- UIA rupture events(In 24 months)
- UIA growth events(In 24 months)
- Change in average Wall Enhancement Index(At baseline and 24th month)
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital
研究点 (1)
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