Early Intensive Antihypertensive Treatment in High-Risk Population of intraCerebral Hemorrhage ExpanSion Predicted by Artificial Intelligence (ARCHES)

Early Intensive Antihypertensive Treatment in High-risk Population of Intracerebral Hemorrhage Expansion Predicted by Artificial Intelligence

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 Overview

• Status: Not yet recruiting
• Conditions: Cerebral Hemorrhage
• Intervention / Treatment: Procedure: Early intensive antihypertensive treatment

• Study Type: Interventional
• Enrollment (Estimated): 680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Na Li, MD, PhD; Phone Number: +8613701086873; Email: selina1808@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ① Age ≥ 18 years;
• ② Arrival at the hospital within 6h of onset, able to complete randomization and receive antihypertensive treatment within 1h of arrival (if the time of onset is unclear, the last normal time will be used);
• ③ CT-confirmed spontaneous supratentorial brain parenchymal hematoma that can break into the ventricles and subarachnoid space, with a hematoma volume of <60 ml;
• ④ Patients at high risk of hematoma expansion with ≥3 points on the artificial intelligence-based hematoma expansion 5-point prediction score;
• ⑤ GCS >8;
• ⑥ SBP in the range of 150-220 mmHg after onset and before randomization;
• ⑦ Signed informed consent by the patient or legal representative.

Exclusion Criteria:

• ① Cerebral hemorrhage is caused by known secondary causes such as trauma, tumors, cerebrovascular malformations, and thrombolysis and thrombus extraction
• ② When the brain parenchyma hemorrhage involves the ventricles, the blood completely fills one lateral ventricle or more than half of both lateral ventricles.
• ③ The hematoma of previous intracerebral hemorrhage has not yet been absorbed
• ④ Surgical treatment is planned within 24 hours
• ⑤ Combination of conditions known to be inappropriate for intensive blood pressure lowering (e.g., severe carotid artery stenosis, vertebral artery or intracranial artery stenosis, smoky or Takayasu's arteritis, and severe heart valve stenosis)
• ⑥Combination of known well-defined indications requiring a more aggressive antihypertensive treatmenr, such as hypertensive encephalopathy or aortic coarctation
• ⑦ Known allergy to antihypertensive drugs
• ⑧Known allergy to antihypertensive drugs (i.e., warfarin with INR > 1.5 or other anticoagulant drugs within the past 24 hours).
• ⑨ With platelet counts less than 50,000/mm3.
• ⑩ Disability due to prior illness mRS ≥ 3
• ⑪ Pregnancy status or within 30 days after delivery
• ⑫ Severe heart or liver disease, severe renal insufficiency (eGFR <30 ml/min) or malignant tumor with life expectancy <3 months.
• ⑬ Currently participating in other interventional clinical trials
• ⑭ Informed consent cannot be obtained.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early intensive antihypertensive treatment group; Treatment starts within 1 hour after randomization; SBP target:130-140 mmHg within 1 hour after treatment; Under the guidance of medication, the researchers can independently select oral + intravenous antihypertensive medications	Procedure: Early intensive antihypertensive treatment; Treatment starts within 1 hour after randomization; SBP target:130-140 mmHg within 1 hour after treatment; 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.).
No Intervention: Standard antihypertensive treatment group; Empirical antihypertensive treatment; SBP target: 140-180 mmHg after randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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);	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

Other Outcome Measures

Outcome Measure	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		During hospitalization
Death during hospitalization		During hospitalization

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Kaijiang Kang, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Antihypertensive Agents
• Other Study ID Numbers: ARCHES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No