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Not yet recruiting Phase 3 NCT07527013

Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

Phase 3 – large-scale trial before approval
Conditions: Endovascular Therapy Acute Ischaemic Stroke Collateral Circulation Blood Pressure Management Prognosis

Sponsor: Beijing Tiantan Hospital

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Stratified Blood Pressure Management
OTHER
Locations 1
China (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing , Beijing Municipality
Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
29.02.2028
Registry ID
NCT07527013
Source
clinicaltrials.gov
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