Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

Official title

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

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.

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 pr

Primary outcome measures

• Proportion of participants with favorable functional outcome at 90 ± 7 days after randomization (mRS 0-2) [Time frame: 90±7 days after randomization]
• Proportion of participants with symptomatic intracranial hemorrhage within 24 ± 4 hours after randomization [Time frame: 24±4 hours after randomization]

Secondary outcome measures (12)

• Proportion of participants with any intracranial hemorrhage within 24 ± 4 hours after randomization [Time frame: 24±4 hours after randomization]
• Proportion of participants with early neurological deterioration within 24 ± 4 hours after randomization [Time frame: 24±4 hours after randomization]
• Rate of recanalization of the occluded target vessel at 24±4 hours after randomization. [Time frame: 24 ± 4 hours after randomization]
• Change in Infarct volume between baseline at 24 ± 4 hours after randomization [Time frame: Baseline and within 24 ± 4 hours after randomization]
• Final infarct volume on CT at 7 ± 1 days after randomization or discharge [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 [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 [Time frame: At 7 ± 1 days after randomization or at discharge, whichever occurs first]
• All-cause mortality 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 [Time frame: 90±7 days after randomization]
• Proportion of participants with excellent functional outcome at 90 ± 7 days after randomization (mRS 0-1) [Time frame: 90±7 days after randomization]
• Proportion of participants with functional independence at 90 ± 7 days after randomization (mRS 0-3) [Time frame: 90±7 days after randomization]
• Health-related quality of life at 90 ± 7 days after randomization assessed by EQ-5D-5L [Time frame: 90 ± 7 days after randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital, Capital Medical University — Beijing

Publications

• Zhang X, Ren X, Zhang Y, Zhang Y, Zhang L, Shen H, Li Z, Xing P, Zhang P, Hua W, Shen F, Tian B, Chen W, Han H, Zhang L, Xu C, Li T, Gao Y, Zhou Y, Zuo Q, Dai D, Zhao R, Li Q, Huang Q, Xu Y, Chen X, Li Q, Song L, Anderson CS, Yang P, Liu J; ENCHANTED2/MT Collaboration. Interaction of brain imaging features and effects of intensive blood pressure lowering after endovascular treatment for acute isch PMID 40330548
• Yang P, Song L, Zhang Y, Zhang X, Chen X, Li Y, Sun L, Wan Y, Billot L, Li Q, Ren X, Shen H, Zhang L, Li Z, Xing P, Zhang Y, Zhang P, Hua W, Shen F, Zhou Y, Tian B, Chen W, Han H, Zhang L, Xu C, Li T, Peng Y, Yue X, Chen S, Wen C, Wan S, Yin C, Wei M, Shu H, Nan G, Liu S, Liu W, Cai Y, Sui Y, Chen M, Zhou Y, Zuo Q, Dai D, Zhao R, Li Q, Huang Q, Xu Y, Deng B, Wu T, Lu J, Wang X, Parsons MW, Butcher PMID 36341753
• Mazighi M, Richard S, Lapergue B, Sibon I, Gory B, Berge J, Consoli A, Labreuche J, Olivot JM, Broderick J, Duhamel A, Touze E, Qureshi AI, Yavchitz A, Escalard S, Desilles JP, Redjem H, Smajda S, Fahed R, Hebert S, Maier B, Delvoye F, Boursin P, Maacha MB, Obadia M, Sabben C, Blanc R, Savatovsky J, Piotin M; BP-TARGET investigators. Safety and efficacy of intensive blood pressure lowering after s PMID 33647246
• Mistry EA, Hart KW, Davis LT, Gao Y, Prestigiacomo CJ, Mittal S, Mehta T, LaFever H, Harker P, Wilson-Perez HE, Beasley KA, Krothapalli N, Lippincott E, Stefek H, Froehler M, Chitale R, Fusco M, Grossman A, Shirani P, Smith M, Jaffa MN, Yeatts SD, Albers GW, Wanderer JP, Tolles J, Lindsell CJ, Lewis RJ, Bernard GR, Khatri P. Blood Pressure Management After Endovascular Therapy for Acute Ischemic S PMID 37668620
• Nam HS, Kim YD, Heo J, Lee H, Jung JW, Choi JK, Lee IH, Lim IH, Hong SH, Baik M, Kim BM, Kim DJ, Shin NY, Cho BH, Ahn SH, Park H, Sohn SI, Hong JH, Song TJ, Chang Y, Kim GS, Seo KD, Lee K, Chang JY, Seo JH, Lee S, Baek JH, Cho HJ, Shin DH, Kim J, Yoo J, Lee KY, Jung YH, Hwang YH, Kim CK, Kim JG, Lee CJ, Park S, Lee HS, Kwon SU, Bang OY, Anderson CS, Heo JH; OPTIMAL-BP Trial Investigators. Intensiv PMID 37668619
• Prabhakaran S, Gonzalez NR, Zachrison KS, Adeoye O, Alexandrov AW, Ansari SA, Chapman S, Czap AL, Dumitrascu OM, Ishida K, Jadhav AP, Johnson B, Johnston KC, Khatri P, Kimberly WT, Lee VH, Leslie-Mazwi TM, Mac Grory B, Madsen TE, Menon B, Mistry EA, Park S, Parker S, Perez de la Ossa N, Reeves M, Saiz T, Scott PA, Schwartzberg D, Sheth SA, Sporns PB, Times S, Tjoumakaris S, Wolfe SQ, Yaghi S; Peer PMID 41582814
• Sandset EC, Anderson CS, Bath PM, Christensen H, Fischer U, Gasecki D, Lal A, Manning LS, Sacco S, Steiner T, Tsivgoulis G. European Stroke Organisation (ESO) guidelines on blood pressure management in acute ischaemic stroke and intracerebral haemorrhage. Eur Stroke J. 2021 Jun;6(2):XLVIII-LXXXIX. doi: 10.1177/23969873211012133. Epub 2021 May 11. PMID 34780578
• Katsanos AH, Malhotra K, Ahmed N, Seitidis G, Mistry EA, Mavridis D, Kim JT, Veroniki AA, Maier I, Matusevicius M, Khatri P, Anadani M, Goyal N, Arthur AS, Sarraj A, Yaghi S, Shoamanesh A, Catanese L, Kantzanou M, Psaltopoulou T, Rentzos A, Psychogios M, Van Adel B, Spiotta AM, Sandset EC, de Havenon A, Alexandrov AV, Petersen NH, Tsivgoulis G. Blood Pressure After Endovascular Thrombectomy and Ou PMID 34772799

Identifiers

NCT: NCT07527013 · RESCUE-BP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗