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.
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；
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;
Parallel
Stratified Blood Pressure Management
Other interventionFor 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.
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.
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.
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.
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.
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.
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.
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Beijing Tiantan Hospital
Lead sponsor
Central Hospital of Dalian University of Technology
Collaborator
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