Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy

NCT07350564 | Recruiting DMC

• 1 other identifier: 240024
• Study Type: interventional
• Target: 910
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

stroke; endovascular thrombectomy; blood pressure; randomised controlled trial

Outcome Measures

Primary Outcomes (3)

• Functional independence at 3 months

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

  At 90 days after randomization

• Symptomatic intracerebral hemorrhage

  Defined by the Heidelberg Bleeding Classification criteria

  At 24±12 hours after randomization

• All-cause mortality

  At 90 days after randomization

Secondary Outcomes (15)

• Excellent outcome

  At 90 days after randomization

• Serious adverse outcome

  At 90 days after randomization

• Shift in scores on the mRS

  At 90 days after randomization

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

  At 24±12 hours after randomization

• NIHSS score at 24 hours

  At 24 hours after randomization

Study Arms (2)

Intensive blood pressure target group

EXPERIMENTAL

Other: Intensive blood pressure management

Standard blood pressure target group

ACTIVE COMPARATOR

Other: Conventional blood pressure management

Interventions

Intensive blood pressure management OTHER

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.

Intensive blood pressure target group

Conventional blood pressure management OTHER

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.

Standard blood pressure target 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hao Yonggang: lead

Study Sites (1)

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair of Neurology

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)