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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
544
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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Proportion of participants with favorable functional outcome at 90 ± 7 days after randomization (mRS 0-2)
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.
Time frame: 90±7 days after randomization
Proportion of participants with symptomatic intracranial hemorrhage within 24 ± 4 hours after randomization
Symptomatic intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification.
Time frame: 24±4 hours after randomization
Proportion of participants with any intracranial hemorrhage within 24 ± 4 hours after randomization
Any intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification.
Time frame: 24±4 hours after randomization
Proportion of participants with early neurological deterioration within 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.
Time frame: 24±4 hours after randomization
Rate of recanalization of the occluded target vessel at 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.
Time frame: 24 ± 4 hours after randomization
Change in Infarct volume between baseline at 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.
Time frame: Baseline and within 24 ± 4 hours after randomization
Final infarct volume on CT at 7 ± 1 days after randomization or discharge
Final infarct volume will be assessed by computed tomography (CT) at 7 ± 1 days after randomization or at hospital discharge, whichever occurs first.
Time frame: 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
Symptomatic intracranial hemorrhage will be assessed according to the Heidelberg Bleeding Classification at 7 ± 1 days after randomization or at discharge, whichever occurs first.
Time frame: 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
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.
Time frame: At 7 ± 1 days after randomization or at discharge, whichever occurs first
All-cause mortality within 90 ± 7 days after randomization
All-cause mortality includes death due to any cause occurring within 90 ± 7 days after randomization.
Time frame: Within 90 ± 7 days after randomization
Distribution of modified Rankin Scale scores at 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.
Time frame: 90±7 days after randomization
Proportion of participants with excellent functional outcome at 90 ± 7 days after randomization (mRS 0-1)
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.
Time frame: 90±7 days after randomization
Proportion of participants with functional independence at 90 ± 7 days after randomization (mRS 0-3)
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.
Time frame: 90±7 days after randomization
Health-related quality of life at 90 ± 7 days after randomization assessed by EQ-5D-5L
Health-related quality of life will be assessed at 90 ± 7 days after randomization using the EQ-5D-5L questionnaire.
Time frame: 90 ± 7 days after randomization
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