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

NCT06242938 | Not Yet Recruiting

• 1 other identifier: ARCHES
• Study Type: interventional
• Target: 680
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Hematoma expansion within 24 hours

  24 hours

• Early neurological deterioration (END) within 24h

  24 hours

• Modified Rankin Scale (mRS) distribution at 90 days

  90 days

• Death at 90 days

  Up to 90 days

• EuroQol-5 Dimensions (EQ-5D) score at 90 days

  90 days

Other Outcomes (3)

• Severe hypoperfusion event

  Up to 180 days

• Treatment-related serious adverse events (SAEs) during hospitalization

  During hospitalization

• Death during hospitalization

  During hospitalization

Study Arms (2)

Early intensive antihypertensive treatment group

EXPERIMENTAL

1. Treatment starts within 1 hour after randomization 2. SBP target:130-140 mmHg within 1 hour after treatment 3. Under the guidance of medication, the researchers can independently select oral + intravenous antihypertensive medications

Procedure: Early intensive antihypertensive treatment

Standard antihypertensive treatment group

NO INTERVENTION

1. Empirical antihypertensive treatment 2. SBP target: 140-180 mmHg after randomization

Interventions

Early intensive antihypertensive treatment PROCEDURE

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.).

Early intensive antihypertensive treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaijiang Kang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Li, MD, PhD

CONTACT

+8613701086873; selina1808@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: February 5, 2024
• Study Start: February 15, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share