Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

NCT07527013 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RESCUE-BP
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endovascular Therapy; Acute Ischaemic Stroke; Collateral Circulation; Blood Pressure Management; Prognosis

Outcome Measures

Primary Outcomes (2)

• 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.

  90±7 days after randomization

• 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.

  24±4 hours after randomization

Secondary Outcomes (12)

• Proportion of participants with any intracranial hemorrhage within 24 ± 4 hours after randomization

  24±4 hours after randomization

• Proportion of participants with early neurological deterioration within 24 ± 4 hours after randomization

  24±4 hours after randomization

• Rate of recanalization of the occluded target vessel at 24±4 hours after randomization.

  24 ± 4 hours after randomization

• Change in Infarct volume between baseline at 24 ± 4 hours after randomization

  Baseline and within 24 ± 4 hours after randomization

• Final infarct volume on CT at 7 ± 1 days after randomization or discharge

  At 7 ± 1 days after randomization or at discharge, whichever occurs first

Study Arms (2)

Stratified blood pressure management group

EXPERIMENTAL

Participants allocated to the intervention arm will be subjected to a stratified blood pressure (BP) management strategy, which is tailored to their pre-procedural pial collateral status as evaluated by the ASITN/SIR collateral grading system.

Other: Stratified Blood Pressure Management

Control group

NO INTERVENTION

Subjects allocated to the control arm will be managed in accordance with the standard-of-care blood pressure targets recommended by prevailing clinical guidelines.

Interventions

Stratified Blood Pressure Management OTHER

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.

Stratified blood pressure management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Central Hospital of Dalian University of Technology: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (9)

• 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 ischaemic stroke: the pre-specified secondary analyses of ENCHANTED2/MT trial. EClinicalMedicine. 2025 Apr 21;83:103197. doi: 10.1016/j.eclinm.2025.103197. eCollection 2025 May.

  PMID: 40330548 RESULT

• 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 K, Campbell B, Robinson TG, Goyal M, Dippel D, Roos Y, Majoie C, Wang L, Wang Y, Liu J, Anderson CS; ENCHANTED2/MT Investigators. Intensive blood pressure control after endovascular thrombectomy for acute ischaemic stroke (ENCHANTED2/MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet. 2022 Nov 5;400(10363):1585-1596. doi: 10.1016/S0140-6736(22)01882-7. Epub 2022 Oct 28.

  PMID: 36341753 RESULT

• 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 successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2021 Apr;20(4):265-274. doi: 10.1016/S1474-4422(20)30483-X. Epub 2021 Feb 26.

  PMID: 33647246 RESULT

• 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 Stroke: The BEST-II Randomized Clinical Trial. JAMA. 2023 Sep 5;330(9):821-831. doi: 10.1001/jama.2023.14330.

  PMID: 37668620 RESULT

• 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. Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke: The OPTIMAL-BP Randomized Clinical Trial. JAMA. 2023 Sep 5;330(9):832-842. doi: 10.1001/jama.2023.14590.

  PMID: 37668619 RESULT

• 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 Review Committee. 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2026 Jan 26. doi: 10.1161/STR.0000000000000513. Online ahead of print.

  PMID: 41582814 RESULT

• 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 RESULT

• 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 Outcomes in Patients With Acute Ischemic Stroke: An Individual Patient Data Meta-analysis. Neurology. 2022 Jan 18;98(3):e291-e301. doi: 10.1212/WNL.0000000000013049. Epub 2021 Nov 12.

  PMID: 34772799 RESULT

• Mistry EA, Mehta T, Mistry A, Arora N, Starosciak AK, De Los Rios La Rosa F, Siegler JE 3rd, Chitale R, Anadani M, Yaghi S, Khatri P, de Havenon A. Blood Pressure Variability and Neurologic Outcome After Endovascular Thrombectomy: A Secondary Analysis of the BEST Study. Stroke. 2020 Feb;51(2):511-518. doi: 10.1161/STROKEAHA.119.027549. Epub 2019 Dec 9.

  PMID: 31813361 RESULT

Central Study Contacts

Liping Liu

CONTACT

+86-010-59978328; lipingsister@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the experimental group needs to perform related operations on patients, the doctors and nurses involved in the study will not be blinded for random patient allocation. However, the grouping of patients will blind neurologists and nurses responsible for conducting neurological, imaging and functional evaluations at baseline and follow-up, as well as collecting clinical outcome data. The randomization information of the patients will also blind the members of the outcome assessment committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)