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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
910
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.
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.
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGFunctional independence at 3 months
A modified Rankin Scale (mRS) score of 0 to 2
Time frame: At 90 days after randomization
Symptomatic intracerebral hemorrhage
Defined by the Heidelberg Bleeding Classification criteria
Time frame: At 24±12 hours after randomization
All-cause mortality
Time frame: At 90 days after randomization
Excellent outcome
A modified Rankin Scale (mRS) score of 0 to 1
Time frame: At 90 days after randomization
Serious adverse outcome
A modified Rankin Scale (mRS) score of 5 to 6
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
NIHSS 0-1 or improvement of more than 8
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)
Health-related quality of life assessed using the EuroQol EQ-5D-3L descriptive system, converted to an index score using \[country\]-specific value set.
Time frame: 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).
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
Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma.
Time frame: An 7 days after randomization
Non-hemorrhagic serious adverse events
Time frame: At 7 days after randomization
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