Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

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

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.

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.