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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early intensive antihypertensive treatment group | Experimental |
|
|
| Standard antihypertensive treatment group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early intensive antihypertensive treatment | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma expansion within 24 hours | Hematoma volume increase ≥6ml on follow up non-contrast CT. | 24 hours |
| Early neurological deterioration (END) within 24h | Within 24 hours after onset, NIHSS increase ≥4 or GCS decreased ≥2 (compared to baseline); |
| Measure | Description | Time Frame |
|---|---|---|
| Severe hypoperfusion event | Including acute kidney injury, severe hypotension, oliguria, acute myocardial infarction, acute cerebral infarction, etc. | Up to 180 days |
| Treatment-related serious adverse events (SAEs) during hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na Li, MD, PhD | Contact | +8613701086873 | selina1808@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kaijiang Kang | Beijing Tiantan Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286617 | Derived | Wu L, Shan S, Kang K, Ye W, Meng X, Li H, Xu Q, Wang A, Li Z, Zhao X, Li N. Early intensive antihypertensive treatment in high-risk population of intracerebral haemorrhage expansion identified by artificial intelligence (ARCHES): study protocol for a multicentre randomised controlled trial. Trials. 2026 Jun 12. doi: 10.1186/s13063-026-09833-x. Online ahead of print. |
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|
| 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. | 90 days |
| Death at 90 days | 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). | 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. | Up to 180 days |
| During hospitalization |
| Death during hospitalization | During hospitalization |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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