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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Intensive blood pressure management; Other: Conventional blood pressure management

• Study Type: Interventional
• Enrollment (Estimated): 910
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The Fourth Affiliated Hospital of Soochow University
      • Contact: Yonggang Hao, Doctor; Phone Number: +8613812636725; Email: hyg3625@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive blood pressure target group	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.
Active Comparator: Standard blood pressure target group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent outcome	A modified Rankin Scale (mRS) score of 0 to 1	At 90 days after randomization
Serious adverse outcome	A modified Rankin Scale (mRS) score of 5 to 6	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
Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours		At 24 hours after randomization
Excellent recovery of NIHSS score at 24 hours	NIHSS 0-1 or improvement of more than 8	At 24 hours after randomization
Change in National Institute of Health Stroke Scale (NIHSS) at 7 days		At 7 days after randomization
Edema volume assessed by CT		At 7 days after randomization
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.	At 90 days after randomization
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).	At 90 days after randomization
Asymptomatic ICH		At 24±12 hours after randomization
Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention		At 7 days after randomization
Extracranial hemorrhage	Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.	An 7 days after randomization
Non-hemorrhagic serious adverse events		At 7 days after randomization

Collaborators and Investigators

• Sponsor: Hao Yonggang

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: stroke; blood pressure; randomised controlled trial; endovascular thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 240024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No