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

NCT ID: NCT06242938

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2025-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early intensive antihypertensive treatment group

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

Group Type: EXPERIMENTAL

Early intensive antihypertensive treatment

Intervention Type: 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.).

Standard antihypertensive treatment group

1. Empirical antihypertensive treatment

2. SBP target: 140-180 mmHg after randomization

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early intensive antihypertensive treatment

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.).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Na Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaijiang Kang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Central Contacts

Na Li, MD, PhD

Role: CONTACT

selina1808@163.com

+8613701086873

Other Identifiers

ARCHES

Identifier Type: -

Identifier Source: org_study_id