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NCT07527013

PHASE3

Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

Official title: Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke (RESCUE-BP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

544

Start Date

2026-06-01

Completion Date

2028-02-29

Last Updated

2026-04-22

Healthy Volunteers

Conditions

Endovascular Therapy Acute Ischaemic Stroke Collateral Circulation Blood Pressure Management Prognosis

Interventions

OTHER

Stratified 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.

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.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China