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.
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
- Conditions the study is for
- Endovascular Therapy, Acute Ischaemic Stroke, Collateral Circulation
- 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);
Show all 9Show fewer
- 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;
Show all 11Show fewer
- 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
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.
- Conditions
- Endovascular Therapy, Acute Ischaemic Stroke, Collateral Circulation, Blood Pressure Management, Prognosis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted14 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endovascular TherapyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital of Dalian University of Technology
- Responsible party
- Principal investigator, Liping Liu, Beijing Tiantan Hospital
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 40330548Yang 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 36341753Mazighi 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 33647246Mistry 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 37668620Nam 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 37668619Prabhakaran 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 41582814Sandset 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 34780578Katsanos 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 34772799Mistry 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified Blood Pressure Management After Endovascular Treatment for Acute Ischemic Stroke (RESCUE-BP)
- ClinicalTrials.gov ID
- NCT07527013
- Acronym / sponsor ID
- RESCUE-BP / RESCUE-BP
- Conditions
- Endovascular Therapy, Acute Ischaemic Stroke, Collateral Circulation, Blood Pressure Management, Prognosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Central Hospital of Dalian University of Technology
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratified blood pressure management group | Experimental | Other: Stratified Blood Pressure ManagementParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stratified Blood Pressure ManagementFor 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. | Other | Stratified blood pressure management group |
Primary outcome
Proportion of participants with favorable functional outcome at 90 ± 7 days after randomization (mRS 0-2)
Time frame: 90±7 days after randomization
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.
Proportion of participants with symptomatic intracranial hemorrhage within 24 ± 4 hours after randomization
Time frame: 24±4 hours after randomization
Symptomatic intracranial hemorrhage will be assessed within 24 ± 4 hours after randomization according to the Heidelberg Bleeding Classification.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 40330548Zhang 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.
- Results publication: PubMed 36341753Yang 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.
- Results publication: PubMed 33647246Mazighi 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.
- Results publication: PubMed 37668620Mistry 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.
- Results publication: PubMed 37668619Nam 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.
- Results publication: PubMed 41582814Prabhakaran 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.
- Results publication: PubMed 34780578Sandset 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.
- Results publication: PubMed 34772799Katsanos 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.
- Results publication: PubMed 31813361Mistry 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.
- Individual participant dataSharing planned: 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.
Related trials for Endovascular Therapy
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Recruiting
SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions
Medium Vessel Occlusion Stroke (MeVO), Stroke Acute
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.