CClinicalTrials.gg
Sign In
RecruitingNCT07350564INTENSEUpdated Jan 20, 2026

Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy

An interventional study of Intensive blood pressure management and Conventional blood pressure management in Stroke, sponsored by Hao Yonggang. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Hao Yonggang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
910
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This clinical trial aims to investigate the safety and efficacy of intensive blood pressure lowering after successful reperfusion with thrombectomy in patients with acute anterior circulation large artery occlusive stroke. The main questions it aims to answer are:

What is the optimal blood pressure range after revascularization with thrombectomy in patients with cerebral embolism? Can intensive blood pressure lowering improve outcomes in cerebral embolism patients following thrombectomy?

Participants will be randomly assigned to either the intervention group, which receives stricter blood pressure control (systolic blood pressure target \<120 mmHg), or the control group, which follows a conventional blood pressure management approach (systolic blood pressure target 140-180 mmHg). Outcomes will be assessed during a 3-month follow-up period.

02

Conditions studied

  • Stroke

Browse trials for

Keywords

  • stroke
  • endovascular thrombectomy
  • blood pressure
  • randomised controlled trial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years
  • To receive endovascular thrombectomy \<24 hours after the onset of symptoms
  • Diagnosed with acute anterior circulation ischemic stroke
  • National Institutes of Health Stroke Scale (NIHSS) score ≤ 30;
  • Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6
  • Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), or Digital Subtraction Angiography (DSA) confirming occlusion of the intracranial internal carotid artery or M1/M2 segment of the middle cerebral artery
  • Successful recanalization of the occluded vessel without in-situ or proximal stenosis (modified Treatment in Cerebral Infarction, mTICI ≥ 2b)
  • Sustained elevated systolic blood pressure (≥140 mmHg for at least two consecutive measurements, separated by >10 minutes) within 3 hours of reperfusion
  • Written informed consent provided by the patient or their legal representative

Exclusion criteria

Exclusion Criteria:

  • Pre-existing stroke disability defined by a modified Rankin score (mRS) >2
  • Unlikely to benefit from or tolerate endovascular thrombectomy, such as severe allergic reaction to contrast agents
  • Failure to achieve mTICI ≥ 2b with endovascular intervention, or presence of in situ or proximal vascular stenosis
  • Patients with contraindications for the use of antihypertensive medications, such as allergy to components
  • Intracranial space-occupying lesions, including brain tumors and vascular malformations
  • Patients with severe liver or renal dysfunction, or those receiving dialysis (severe liver dysfunction is defined as alanine aminotransferase [ALT] > 3 times the upper limit of normal or aspartate aminotransferase [AST] > 3 times the upper limit of normal; severe renal dysfunction is defined as serum creatinine > 3.0 mg/dL [265.2 μmol/L] or glomerular filtration rate [GFR] \< 30 mL/min/1.73 m²)
  • Serious illness with life expectancy of \<6 months
  • Lactating women
  • Participation in other interventional clinical trials within the past 3 months;
  • Any other conditions that render patients unsuitable for participation in this study or unable to complete the study process, such as psychiatric disorders, cognitive or emotional impairments, or physical conditions that hinder compliance with study procedures and follow-up
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
910 participants (estimated)

Study arms

  • Experimental
    Intensive blood pressure target group

    Other: Intensive blood pressure management

  • Active comparator
    Standard blood pressure target group

    Other: Conventional blood pressure management

Interventions

  • OtherIntensive blood pressure management

    The objective is to achieve a systolic blood pressure (SBP) \<120 mmHg within 1 hour after randomization and maintain this target for 48 hours. Intravenous titration is initiated immediately after randomization, with an SBP of 100 mmHg used as the threshold for discontinuing antihypertensive therapy or initiating vasopressors.

  • OtherConventional blood pressure management

    The objective is to maintain an SBP of 140-180 mmHg within 1 hour after randomization and sustain this range for 48 hours. Intravenous antihypertensive agents are administered when SBP exceeds 180 mmHg and discontinued once SBP is ≤150 mmHg.

05

What researchers measure

Primary outcomes

  1. Functional independence at 3 months

    A modified Rankin Scale (mRS) score of 0 to 2

    Time frame: At 90 days after randomization

  2. Symptomatic intracerebral hemorrhage

    Defined by the Heidelberg Bleeding Classification criteria

    Time frame: At 24±12 hours after randomization

  3. All-cause mortality

    Time frame: At 90 days after randomization

Secondary outcomes

  1. Excellent outcome

    A modified Rankin Scale (mRS) score of 0 to 1

    Time frame: At 90 days after randomization

  2. Serious adverse outcome

    A modified Rankin Scale (mRS) score of 5 to 6

    Time frame: At 90 days after randomization

  3. Shift in scores on the mRS

    Time frame: At 90 days after randomization

  4. Infarct volume at follow-up CT scan (24±12h)

    Time frame: At 24±12 hours after randomization

  5. NIHSS score at 24 hours

    Time frame: At 24 hours after randomization

  6. Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours

    Time frame: At 24 hours after randomization

  7. Excellent recovery of NIHSS score at 24 hours

    NIHSS 0-1 or improvement of more than 8

    Time frame: At 24 hours after randomization

  8. Change in National Institute of Health Stroke Scale (NIHSS) at 7 days

    Time frame: At 7 days after randomization

  9. Edema volume assessed by CT

    Time frame: At 7 days after randomization

  10. Health-related quality of life (EQ-5D-3L index score)

    Health-related quality of life assessed using the EuroQol EQ-5D-3L descriptive system, converted to an index score using \[country\]-specific value set.

    Time frame: At 90 days after randomization

  11. Health-related quality of life (EQ-5D VAS)

    Self-rated health status assessed using the EuroQol visual analog scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).

    Time frame: At 90 days after randomization

  12. Asymptomatic ICH

    Time frame: At 24±12 hours after randomization

  13. Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention

    Time frame: At 7 days after randomization

  14. Extracranial hemorrhage

    Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.

    Time frame: An 7 days after randomization

  15. Non-hemorrhagic serious adverse events

    Time frame: At 7 days after randomization

06

Study locations

1 of 1 sites recruiting
  • The Fourth Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215000, China
    Recruiting
07

References and documents

Study documents

  • Study protocol · Aug 3, 2024

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT07350564
Lead sponsor
Hao Yonggang
Responsible party
Hao Yonggang (Vice Chair of Neurology, The Fourth Affiliated Hospital of Soochow University) — Sponsor-investigator
First posted
Jan 20, 2026
Start date
Nov 1, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 20, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke→

Other studies from this sponsor

Hao Yonggang

Start the discussion