Intensive Blood Pressure Control After Endovascular Thrombectomy for Acute Embolic Stroke (INTENSE): a Multicentre, Open-label, Blinded-endpoint, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 910
研究概览
简要总结
This clinical trial aims to investigate the safety and efficacy of intensive blood pressure lowering after successful reperfusion with thrombectomy in patients with acute anterior circulation large artery occlusive stroke. The main questions it aims to answer are:
What is the optimal blood pressure range after revascularization with thrombectomy in patients with cerebral embolism? Can intensive blood pressure lowering improve outcomes in cerebral embolism patients following thrombectomy?
Participants will be randomly assigned to either the intervention group, which receives stricter blood pressure control (systolic blood pressure target <120 mmHg), or the control group, which follows a conventional blood pressure management approach (systolic blood pressure target 140-180 mmHg). Outcomes will be assessed during a 3-month follow-up period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •To receive endovascular thrombectomy <24 hours after the onset of symptoms
- •Diagnosed with acute anterior circulation ischemic stroke
- •National Institutes of Health Stroke Scale (NIHSS) score ≤ 30;
- •Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6
- •Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), or Digital Subtraction Angiography (DSA) confirming occlusion of the intracranial internal carotid artery or M1/M2 segment of the middle cerebral artery
- •Successful recanalization of the occluded vessel without in-situ or proximal stenosis (modified Treatment in Cerebral Infarction, mTICI ≥ 2b)
- •Sustained elevated systolic blood pressure (≥140 mmHg for at least two consecutive measurements, separated by >10 minutes) within 3 hours of reperfusion
- •Written informed consent provided by the patient or their legal representative
排除标准
- •Pre-existing stroke disability defined by a modified Rankin score (mRS) >2
- •Unlikely to benefit from or tolerate endovascular thrombectomy, such as severe allergic reaction to contrast agents
- •Failure to achieve mTICI ≥ 2b with endovascular intervention, or presence of in situ or proximal vascular stenosis
- •Patients with contraindications for the use of antihypertensive medications, such as allergy to components
- •Intracranial space-occupying lesions, including brain tumors and vascular malformations
- •Patients with severe liver or renal dysfunction, or those receiving dialysis (severe liver dysfunction is defined as alanine aminotransferase [ALT] > 3 times the upper limit of normal or aspartate aminotransferase [AST] > 3 times the upper limit of normal; severe renal dysfunction is defined as serum creatinine > 3.0 mg/dL [265.2 μmol/L] or glomerular filtration rate [GFR] < 30 mL/min/1.73 m²)
- •Serious illness with life expectancy of <6 months
- •Lactating women
- •Participation in other interventional clinical trials within the past 3 months;
- •Any other conditions that render patients unsuitable for participation in this study or unable to complete the study process, such as psychiatric disorders, cognitive or emotional impairments, or physical conditions that hinder compliance with study procedures and follow-up
研究者
Hao Yonggang
Vice Chair of Neurology
The Fourth Affiliated Hospital of Soochow University