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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Fourth Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 910
Treatments
Experimental: Intensive blood pressure target group
Active_comparator: Standard blood pressure target group
Related Therapeutic Areas
Sponsors
Leads: Hao Yonggang

This content was sourced from clinicaltrials.gov