The goal of this clinical trial is to clarify the efficacy, safety and feasibility of early intensive antihypertensive treantment in intracerebral hemorrhage (ICH) patients at high risk of hematoma expansion based on artificial intelligence prediction. The main question it aims to answer are: * Can ICH patients at high risk of hematoma expansion based on artificial intelligence prediction benefit from early intensive antihypertensive treatment? * Is early intensive antihypertensive treatment safe to patients at high risk of hematoma expansion based on artificial intelligence prediction. Participants will accept intensive antihypertensive treatment (target systolic blood pressure: 130-140mmHg) at early stage (within 1 hour after randomization) of cerebral hemorrhage and maitain the target blood pressure for 7 days. Researchers will compare standard treatment group (target systolic blood pressure 140-180mmHg after randomization) to see if intensive antihypertensive treatment can improve the outcome of patients with ICH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
680
1. Treatment starts within 1 hour after randomization 2. SBP target:130-140 mmHg within 1 hour after treatment 3. The researchers can independently select oral + intravenous antihypertensive medications. Any type of antihypertensive drugs can be selected (eg. β-blokers, α-blockers, CCBs, ARBs/ACEIs, diuretic, etc.).
Death or severe disability (modified Rankin Scale 3-6) at 90 days
Death or severe disability is defined as modified Rankin Scale (mRS) 3-6. The mRS is a scale used to measure the degree of disability caused by stroke or other neurological conditions. It ranges from 0 (no symptoms) to 6 (death). The lower the score, the less severe the disability.
Time frame: 90 days
Hematoma expansion within 24 hours
Hematoma volume increase ≥6ml on follow up non-contrast CT.
Time frame: 24 hours
Early neurological deterioration (END) within 24h
Within 24 hours after onset, NIHSS increase ≥4 or GCS decreased ≥2 (compared to baseline);
Time frame: 24 hours
Modified Rankin Scale (mRS) distribution at 90 days
The mRS is a scale used to measure the degree of disability caused by stroke or other neurological conditions. It ranges from 0 (no symptoms) to 6 (death). The lower the score, the less severe the disability.
Time frame: 90 days
Death at 90 days
Time frame: Up to 90 days
EuroQol-5 Dimensions (EQ-5D) score at 90 days
The EQ-5D is a standardized instrument for measuring generic health status developed by the EuroQol Group. It assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels: no problems, some problems, and severe problems. The EQ-5D scores range from -0.594 to 1, where 1 represents full health and 0 represents death. Lower scores indicate poorer health. The EQ-5D is commonly used in economic evaluations of health care interventions to assess quality-adjusted life years (QALYs).
Time frame: 90 days
Death or severe disability (modified Rankin Scale 3-6) at 180 days
Death or severe disability is defined as modified Rankin Scale (mRS) 3-6. The mRS is a scale used to measure the degree of disability caused by stroke or other neurological conditions. It ranges from 0 (no symptoms) to 6 (death). The lower the score, the less severe the disability.
Time frame: Up to 180 days
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