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NCT Number: NCT07350564

Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Yonggang Hao, Doctor

CONTACT

[email protected]

+8613812636725

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Functional independence at 3 months

    Time frame: At 90 days after randomization

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

  2. Symptomatic intracerebral hemorrhage

    Time frame: At 24±12 hours after randomization

    Defined by the Heidelberg Bleeding Classification criteria

  3. All-cause mortality

    Time frame: At 90 days after randomization

Secondary outcomes

  1. Excellent outcome

    Time frame: At 90 days after randomization

    A modified Rankin Scale (mRS) score of 0 to 1

  2. Serious adverse outcome

    Time frame: At 90 days after randomization

    A modified Rankin Scale (mRS) score of 5 to 6

  3. Shift in scores on the mRS

    Time frame: At 90 days after randomization

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

    Time frame: At 24±12 hours after randomization

  5. NIHSS score at 24 hours

    Time frame: At 24 hours after randomization

  6. Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours

    Time frame: At 24 hours after randomization

  7. Excellent recovery of NIHSS score at 24 hours

    Time frame: At 24 hours after randomization

    NIHSS 0-1 or improvement of more than 8

  8. Change in National Institute of Health Stroke Scale (NIHSS) at 7 days

    Time frame: At 7 days after randomization

  9. Edema volume assessed by CT

    Time frame: At 7 days after randomization

  10. Health-related quality of life (EQ-5D-3L index score)

    Time frame: At 90 days after randomization

    Health-related quality of life assessed using the EuroQol EQ-5D-3L descriptive system, converted to an index score using [country]-specific value set.

  11. Health-related quality of life (EQ-5D VAS)

    Time frame: At 90 days after randomization

    Self-rated health status assessed using the EuroQol visual analog scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).

  12. Asymptomatic ICH

    Time frame: At 24±12 hours after randomization

  13. Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention

    Time frame: At 7 days after randomization

  14. Extracranial hemorrhage

    Time frame: An 7 days after randomization

    Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.

  15. Non-hemorrhagic serious adverse events

    Time frame: At 7 days after randomization

Sponsors and collaborators

Lead sponsor

Hao Yonggang

Other

Registry information

Official study title

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

Acronym: INTENSE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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