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Endovascular TherapyPhase 3RESCUE-BPNCT07527013

Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke

A Phase 3 study testing Stratified Blood Pressure Management in people with Endovascular Therapy and Acute Ischaemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stratified Blood Pressure Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 participants
Where
1 siteChina
Study dates
1 Jun 2026to 29 Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

    Liping Liu, +86-010-59978328, lipingsister@gmail.com

Other trials in China

About this study

Official title: 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.

Being tested
Stratified Blood Pressure Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stratified Blood Pressure ManagementOther

    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.

Study groups in NCT07527013
Study groupRoleWhat they receive
Stratified blood pressure management groupExperimentalParticipants 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.
Receives: Other: Stratified Blood Pressure Management
Control groupNo interventionSubjects allocated to the control arm will be managed in accordance with the standard-of-care blood pressure targets recommended by prevailing clinical guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90±7 days after randomization

  2. 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.

    Measured: 24±4 hours after randomization

Secondary outcomes (12)
  1. Proportion of participants with any intracranial hemorrhage within 24 ± 4 hours after randomization

    Any intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification.

    Measured: 24±4 hours after randomization

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

    Early neurological deterioration is defined as an increase of 4 points or more in the National Institutes of Health Stroke Scale (NIHSS) score compared with baseline.

    Measured: 24±4 hours after randomization

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

    Recanalization of the occluded target vessel defined as an Arterial Occlusive Lesion [AOL] score of 2-3 on CTA or MRA.

    Measured: 24 ± 4 hours after randomization

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

    Infarct volume will be measured at baseline and again within 24 ± 4 hours after randomization using magnetic resonance imaging (MRI) or computed tomography perfusion (CTP). The change in infarct volume from baseline will be analyzed and compared between the two groups.

    Measured: Baseline and within 24 ± 4 hours after randomization

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

    Final infarct volume will be assessed by computed tomography (CT) at 7 ± 1 days after randomization or at hospital discharge, whichever occurs first.

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

  6. Proportion of participants with symptomatic intracranial hemorrhage at 7 ± 1 days after randomization or at discharge, whichever occurs first

    Symptomatic intracranial hemorrhage will be assessed according to the Heidelberg Bleeding Classification at 7 ± 1 days after randomization or at discharge, whichever occurs first.

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

  7. NIHSS score at 7 ± 1 days after randomization or at discharge, whichever occurs first

    Neurological deficit will be assessed using the National Institutes of Health Stroke Scale (NIHSS) at 7 ± 1 days after randomization or at discharge, whichever occurs first. The National Institutes of Health Stroke Scale (NIHSS) is a standardized, quantitative assessment tool used by healthcare providers to objectively evaluate and quantify the neurological deficit and severity of impairment in patients with acute ischemic stroke. Total Score Range: 0 to 42. A higher total score indicates greater neurological impairment.

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

  8. All-cause mortality within 90 ± 7 days after randomization

    All-cause mortality includes death due to any cause occurring within 90 ± 7 days after randomization.

    Measured: Within 90 ± 7 days after randomization

  9. Distribution of modified Rankin Scale scores at 90 ± 7 days after randomization

    Functional outcome will be evaluated using the full distribution of modified Rankin Scale (mRS) scores 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.

    Measured: 90±7 days after randomization

  10. Proportion of participants with excellent functional outcome at 90 ± 7 days after randomization (mRS 0-1)

    Excellent functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 1 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.

    Measured: 90±7 days after randomization

  11. Proportion of participants with functional independence at 90 ± 7 days after randomization (mRS 0-3)

    Functional independence is defined as a modified Rankin Scale (mRS) score of 0 to 3 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.

    Measured: 90±7 days after randomization

  12. Health-related quality of life at 90 ± 7 days after randomization assessed by EQ-5D-5L

    Health-related quality of life will be assessed at 90 ± 7 days after randomization using the EQ-5D-5L questionnaire.

    Measured: 90 ± 7 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
544 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527013
Sponsor's protocol ID
RESCUE-BP
Acronym
RESCUE-BP
Status last verified
Apr 2026
First submitted
8 Apr 2026
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The principal researcher holds complete intellectual property rights. The entire research process and data analysis process strictly protected the information of the subjects. There is not a plan to make individual patient data (IPD) available. Sharing IPD will require IRB approval from Tiantan Hospital and other participating institutes in China.

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 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.

    PubMed 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 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.

    PubMed 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 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.

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

    PubMed 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. 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.

    PubMed 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 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 Aug;57(8):e316-e436. doi: 10.1161/STR.0000000000000513. Epub 2026 Jan 26.

    PubMed 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.

    PubMed 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 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.

    PubMed 34772799
  • 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.

    PubMed 31813361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stratified Blood Pressure Management in people with Endovascular Therapy and Acute Ischaemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liping Liu (+86-010-59978328, lipingsister@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with favorable functional outcome at 90 ± 7 days after randomization (mRS 0-2) (time frame: 90±7 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527013, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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