Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy

Official title

Intensive Blood Pressure Control After Endovascular Thrombectomy for Acute Embolic Stroke (INTENSE): a Multicentre, Open-label, Blinded-endpoint, Randomised Controlled Trial

Overview

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.

Interventions

• Other Intensive 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.
• Other Conventional 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.

Primary outcome measures

• Functional independence at 3 months [Time frame: At 90 days after randomization]
• Symptomatic intracerebral hemorrhage [Time frame: At 24±12 hours after randomization]
• All-cause mortality [Time frame: At 90 days after randomization]

Secondary outcome measures (12)

• Excellent outcome [Time frame: At 90 days after randomization]
• Serious adverse outcome [Time frame: At 90 days after randomization]
• Shift in scores on the mRS [Time frame: At 90 days after randomization]
• Infarct volume at follow-up CT scan (24±12h) [Time frame: At 24±12 hours after randomization]
• NIHSS score at 24 hours [Time frame: At 24 hours after randomization]
• Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours [Time frame: At 24 hours after randomization]
• Excellent recovery of NIHSS score at 24 hours [Time frame: At 24 hours after randomization]
• Change in National Institute of Health Stroke Scale (NIHSS) at 7 days [Time frame: At 7 days after randomization]
• Edema volume assessed by CT [Time frame: At 7 days after randomization]
• Health-related quality of life (EQ-5D-3L index score) [Time frame: At 90 days after randomization]
• Health-related quality of life (EQ-5D VAS) [Time frame: At 90 days after randomization]
• Asymptomatic ICH [Time frame: At 24±12 hours after randomization]

Eligibility criteria

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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Fourth Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07350564 · 240024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗