Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke (RESCUE-BP)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 544
- 试验地点
- 1
- 主要终点
- Proportion of participants with symptomatic intracranial hemorrhage within 24 ± 4 hours after randomization
研究概览
简要总结
The RESCUE-BP is a multi-centered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. In patients with acute ischemic stroke who have undergone endovascular treatment and achieved successful recanalization, the evaluation will compare a stratified blood pressure management strategy based on the collateral circulation status with the guideline-recommended conventional blood pressure management strategy. Within each stratum, participants will be randomized in a 1:1 ratio to either the stratified blood pressure management strategy group or the guideline-recommended conventional blood pressure management group. The goal is to determine whether this can improve good functional outcomes at 90 days (90-day Modified Rankin Scale [mRS] score 0-2).
The study consists of four visits including the day of randomization, 24±4 hours after randomization, 7±1 days after randomization and 90±7 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment, neurological function rating scale will be recorded during the program.
The primary outcome is the modified Rankin Scale (mRS) score of 0 to 2 at 90±7 days after randomization. The primary safety outcome is the incidence of sICH within 24±4 hours after randomization.
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
Since the experimental group needs to perform related operations on patients, the doctors and nurses involved in the study will not be blinded for random patient allocation. However, the grouping of patients will blind neurologists and nurses responsible for conducting neurological, imaging and functional evaluations at baseline and follow-up, as well as collecting clinical outcome data. The randomization information of the patients will also blind the members of the outcome assessment committee.
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；
- •Clinical diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (internal carotid artery or M1/M2 segment of the middle cerebral artery)；
- •Received EVT (including direct EVT and bridging therapy) within 24 hours of symptom onset；
- •Baseline ASPECTS score ≥ 3；
- •Baseline NIHSS score ≥ 6；
- •Successful recanalization achieved post-procedure (defined as expanded Thrombolysis in Cerebral Infarction [eTICI] grade ≥ 2b50);
- •Two consecutive systolic blood pressure (SBP) measurements ≥ 150 mmHg within 3 hours post-recanalization (with a measurement interval of no less than 5 minutes)；
- •Able to complete randomization within 3 hours post-recanalization；
- •Informed consent signed by the patient or their legal representative.
排除标准
- •Pre-stroke mRS score > 1；
- •Comatose state (Glasgow Coma Scale [GCS] score < 8);
- •Symptomatic intracerebral hemorrhage occurred before randomization;
- •Within the past 3 months, occurrence of acute ST-segment elevation myocardial infarction (MI), acute decompensated heart failure, QTc > 500 ms, hospitalization or involuntary coronary intervention due to acute coronary syndrome, MI, or cardiac arrest; or heart failure (New York Heart Association [NYHA] class III/IV or left ventricular ejection fraction < 35%); or known history of ventricular tachycardia;
- •History of severe renal insufficiency, acute renal failure, dialysis, or estimated glomerular filtration rate (eGFR) < 20 ml/min/1.72m²;
- •History of severe hepatic disease, or Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) and/or Gamma-Glutamyl Transferase (GGT) ≥ 3×ULN and/or Total Bilirubin (TBIL) ≥ 2×ULN;
- •Aortic dissection, cervical artery dissection, or cerebral artery dissection; unruptured aortic aneurysm or cerebral aneurysm; or known arteriovenous malformation;
- •Comorbidities with a life expectancy < 6 months (e.g., malignant tumors);
- •Pregnant or lactating women;
- •Participation in another clinical trial within the past 30 days;
- •Any clinical condition judged by the research team that might limit compliance with study procedures.
研究组 & 干预措施
Control group
Subjects allocated to the control arm will be managed in accordance with the standard-of-care blood pressure targets recommended by prevailing clinical guidelines.
Stratified blood pressure management group
Participants allocated to the intervention arm will be subjected to a stratified blood pressure (BP) management strategy, which is tailored to their pre-procedural pial collateral status as evaluated by the ASITN/SIR collateral grading system.
干预措施: Stratified Blood Pressure Management (Other)
结局指标
主要结局
Proportion of participants with symptomatic intracranial hemorrhage within 24 ± 4 hours after randomization
时间窗: 24±4 hours after randomization
Symptomatic intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification.
Proportion of participants with favorable functional outcome at 90 ± 7 days after randomization (mRS 0-2)
时间窗: 90±7 days after randomization
Favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 2 at 90 ± 7 days after randomization. The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.
次要结局
- Proportion of participants with any intracranial hemorrhage within 24 ± 4 hours after randomization(24±4 hours after randomization)
- Proportion of participants with early neurological deterioration within 24 ± 4 hours after randomization(24±4 hours after randomization)
- Rate of recanalization of the occluded target vessel at 24±4 hours after randomization.(24 ± 4 hours after randomization)
- Change in Infarct volume between baseline at 24 ± 4 hours after randomization(Baseline and within 24 ± 4 hours after randomization)
- Final infarct volume on CT at 7 ± 1 days after randomization or discharge(At 7 ± 1 days after randomization or at discharge, whichever occurs first)
- Proportion of participants with symptomatic intracranial hemorrhage at 7 ± 1 days after randomization or at discharge, whichever occurs first(At 7 ± 1 days after randomization or at discharge, whichever occurs first)
- All-cause mortality within 90 ± 7 days after randomization(Within 90 ± 7 days after randomization)
- Health-related quality of life at 90 ± 7 days after randomization assessed by EQ-5D-5L(90 ± 7 days after randomization)
- NIHSS score at 7 ± 1 days after randomization or at discharge, whichever occurs first(At 7 ± 1 days after randomization or at discharge, whichever occurs first)
- Distribution of modified Rankin Scale scores at 90 ± 7 days after randomization(90±7 days after randomization)
- Proportion of participants with excellent functional outcome at 90 ± 7 days after randomization (mRS 0-1)(90±7 days after randomization)
- Proportion of participants with functional independence at 90 ± 7 days after randomization (mRS 0-3)(90±7 days after randomization)
研究者
Liping Liu
Professor
Beijing Tiantan Hospital