StrokeINTENSENCT07350564
Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy
A study testing Intensive blood pressure management and Conventional blood pressure management in people with Stroke, run by Hao Yonggang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Intensive blood pressure management and Conventional blood pressure management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Yonggang Hao, Doctor, +8613812636725, hyg3625@126.com
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Intensive blood pressure management, Conventional blood pressure management
- Keywords
- stroke, endovascular thrombectomy, blood pressure, randomised controlled trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive blood pressure managementOther
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 managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive blood pressure target group | Experimental | Not described Receives: Other: Intensive blood pressure management |
| Standard blood pressure target group | Active comparator | Not described Receives: Other: Conventional blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at 3 months
A modified Rankin Scale (mRS) score of 0 to 2
Measured: At 90 days after randomization
Symptomatic intracerebral hemorrhage
Defined by the Heidelberg Bleeding Classification criteria
Measured: At 24±12 hours after randomization
All-cause mortality
Measured: At 90 days after randomization
Secondary outcomes (15)
Excellent outcome
A modified Rankin Scale (mRS) score of 0 to 1
Measured: At 90 days after randomization
Serious adverse outcome
A modified Rankin Scale (mRS) score of 5 to 6
Measured: At 90 days after randomization
Shift in scores on the mRS
Measured: At 90 days after randomization
Infarct volume at follow-up CT scan (24±12h)
Measured: At 24±12 hours after randomization
NIHSS score at 24 hours
Measured: At 24 hours after randomization
Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours
Measured: At 24 hours after randomization
Excellent recovery of NIHSS score at 24 hours
NIHSS 0-1 or improvement of more than 8
Measured: At 24 hours after randomization
Change in National Institute of Health Stroke Scale (NIHSS) at 7 days
Measured: At 7 days after randomization
Edema volume assessed by CT
Measured: 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.
Measured: 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).
Measured: At 90 days after randomization
Asymptomatic ICH
Measured: At 24±12 hours after randomization
Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention
Measured: At 7 days after randomization
Extracranial hemorrhage
Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.
Measured: An 7 days after randomization
Non-hemorrhagic serious adverse events
Measured: At 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hao Yonggang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hao Yonggang, The Fourth Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350564
- Sponsor's protocol ID
- 240024
- Acronym
- INTENSE
- Status last verified
- Jan 2026
- First submitted
- 25 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Blood Pressure Control After Endovascular Thrombectomy for Acute Embolic Stroke (INTENSE): a Multicentre, Open-label, Blinded-endpoint, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07350564
- Acronym / sponsor ID
- INTENSE / 240024
- Conditions
- Stroke
- Keywords
- stroke, endovascular thrombectomy, blood pressure, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Hao YonggangUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive blood pressure target group | Experimental | Other: Intensive blood pressure management |
| Standard blood pressure target group | Active comparator | Other: Conventional blood pressure management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive blood pressure managementThe 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 | Intensive blood pressure target group |
| Conventional blood pressure managementThe 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. | Other | Standard blood pressure target group |
Primary outcome
Functional independence at 3 months
Time frame: At 90 days after randomization
A modified Rankin Scale (mRS) score of 0 to 2
Symptomatic intracerebral hemorrhage
Time frame: At 24±12 hours after randomization
Defined by the Heidelberg Bleeding Classification criteria
All-cause mortality
Time frame: At 90 days after randomization
15 secondary outcomes
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
Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention
Time frame: At 7 days after randomization
Extracranial hemorrhage
Time frame: An 7 days after randomization
Non-hemorrhagic serious adverse events
Time frame: At 7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive blood pressure management and Conventional blood pressure management in people with Stroke, run by Hao Yonggang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at 3 months (time frame: At 90 days after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.