Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy (INTENSE)

Hao Yonggang

Status

Enrolling

Conditions

Stroke

Treatments

Other: Conventional blood pressure management

Other: Intensive blood pressure management

Study type

Interventional

Funder types

Other

Identifiers

NCT07350564

240024

Details and patient eligibility

About

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.

Enrollment

910 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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