Acute Ischaemic Stroke, Blood Pressure Management, Collateral Circulation, Endovascular Therapy, Prognosis
Conditions
Brief summary
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.
Interventions
OTHERStratified Blood Pressure Management
For participants in the intervention arm whose systolic blood pressure (SBP) exceeds the assigned target post-randomization, antihypertensive therapy must be initiated immediately within the neurology ward or neuro intensive care unit. The SBP should be brought below the designated target within 2 hours and maintained within the assigned range for the subsequent 24 hours (or until hospital discharge or death, whichever occurs first). The BP-lowering process must be smooth and gradual to avoid precipitous drops or severe fluctuations. The SBP target is determined by the following criteria: Safety Constraint: The maximum reduction in SBP must not exceed 20% relative to the baseline BP measured at randomization. Stratified Targets based on Collateral Status: ASITN/SIR Grade 0-2; ASITN/SIR Grade 3-4.
Sponsors
Beijing Tiantan Hospital
Central Hospital of Dalian University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with favorable functional outcome at 90 ± 7 days after randomization (mRS 0-2) | 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. |
| Proportion of participants with symptomatic intracranial hemorrhage within 24 ± 4 hours after randomization | 24±4 hours after randomization | Symptomatic intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with any intracranial hemorrhage within 24 ± 4 hours after randomization | 24±4 hours after randomization | Any intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification. |
| Proportion of participants with early neurological deterioration within 24 ± 4 hours after randomization | 24±4 hours after randomization | Early neurological deterioration is defined as an increase of 4 points or more in the National Institutes of Health Stroke Scale (NIHSS) score compared with baseline. |
| Rate of recanalization of the occluded target vessel at 24±4 hours after randomization. | 24 ± 4 hours after randomization | Recanalization of the occluded target vessel defined as an Arterial Occlusive Lesion \[AOL\] score of 2-3 on CTA or MRA. |
| Change in Infarct volume between baseline at 24 ± 4 hours after randomization | Baseline and within 24 ± 4 hours after randomization | Infarct volume will be measured at baseline and again within 24 ± 4 hours after randomization using magnetic resonance imaging (MRI) or computed tomography perfusion (CTP). The change in infarct volume from baseline will be analyzed and compared between the two groups. |
| 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 | Final infarct volume will be assessed by computed tomography (CT) at 7 ± 1 days after randomization or at hospital 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 | Symptomatic intracranial hemorrhage will be assessed according to the Heidelberg Bleeding Classification at 7 ± 1 days after randomization or at discharge, whichever occurs first. |
| 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 | Neurological deficit will be assessed using the National Institutes of Health Stroke Scale (NIHSS) at 7 ± 1 days after randomization or at discharge, whichever occurs first. The National Institutes of Health Stroke Scale (NIHSS) is a standardized, quantitative assessment tool used by healthcare providers to objectively evaluate and quantify the neurological deficit and severity of impairment in patients with acute ischemic stroke. Total Score Range: 0 to 42. A higher total score indicates greater neurological impairment. |
| All-cause mortality within 90 ± 7 days after randomization | Within 90 ± 7 days after randomization | All-cause mortality includes death due to any cause occurring within 90 ± 7 days after randomization. |
| Distribution of modified Rankin Scale scores at 90 ± 7 days after randomization | 90±7 days after randomization | Functional outcome will be evaluated using the full distribution of modified Rankin Scale (mRS) scores 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. |
| Proportion of participants with excellent functional outcome at 90 ± 7 days after randomization (mRS 0-1) | 90±7 days after randomization | Excellent functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 1 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. |
| Proportion of participants with functional independence at 90 ± 7 days after randomization (mRS 0-3) | 90±7 days after randomization | Functional independence is defined as a modified Rankin Scale (mRS) score of 0 to 3 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. |
| Health-related quality of life at 90 ± 7 days after randomization assessed by EQ-5D-5L | 90 ± 7 days after randomization | Health-related quality of life will be assessed at 90 ± 7 days after randomization using the EQ-5D-5L questionnaire. |
Countries
China
Contacts
CONTACTLiping Liu
Outcome results
None listed