Cerebral HemorrhageARCHESNCT06242938
Early Intensive Antihypertensive Treatment in High-Risk Population of intraCerebral Hemorrhage ExpanSion Predicted by Artificial Intelligence
A study testing Early intensive antihypertensive treatment in people with Cerebral Hemorrhage, run by Beijing Tiantan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage
- What is being tested?
- Early intensive antihypertensive treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
Read more
- 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
- Being tested
- Early intensive antihypertensive treatment
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intensive antihypertensive treatmentProcedure or surgery
- 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.).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Early intensive antihypertensive treatment |
| Standard antihypertensive treatment group | No intervention | 1. Empirical antihypertensive treatment 2. SBP target: 140-180 mmHg after randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (6)
Hematoma expansion within 24 hours
Hematoma volume increase ≥6ml on follow up non-contrast CT.
Measured: 24 hours
Early neurological deterioration (END) within 24h
Within 24 hours after onset, NIHSS increase ≥4 or GCS decreased ≥2 (compared to baseline);
Measured: 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.
Measured: 90 days
Death at 90 days
Measured: 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).
Measured: 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.
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Li, Beijing Tiantan Hospital
- Investigators
- Kaijiang Kang, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242938
- Sponsor's protocol ID
- ARCHES
- Acronym
- ARCHES
- Status last verified
- Feb 2024
- First submitted
- 3 Dec 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42286617
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intensive Antihypertensive Treatment in High-risk Population of Intracerebral Hemorrhage Expansion Predicted by Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06242938
- Acronym / sponsor ID
- ARCHES / ARCHES
- Conditions
- Cerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intensive antihypertensive treatment group | Experimental | Procedure: Early intensive antihypertensive treatment1. 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 |
| Standard antihypertensive treatment group | No intervention | –1. Empirical antihypertensive treatment 2. SBP target: 140-180 mmHg after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early intensive antihypertensive treatment1. 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.). | Procedure or surgery | Early intensive antihypertensive treatment group |
Primary outcome
Death or severe disability (modified Rankin Scale 3-6) at 90 days
Time frame: 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.
6 secondary outcomes
Hematoma expansion within 24 hours
Time frame: 24 hours
Early neurological deterioration (END) within 24h
Time frame: 24 hours
Modified Rankin Scale (mRS) distribution at 90 days
Time frame: 90 days
Death at 90 days
Time frame: Up to 90 days
EuroQol-5 Dimensions (EQ-5D) score at 90 days
Time frame: 90 days
Death or severe disability (modified Rankin Scale 3-6) at 180 days
Time frame: Up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 42286617Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaijiang Kang principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Early intensive antihypertensive treatment in people with Cerebral Hemorrhage, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Li, MD, PhD (+8613701086873, selina1808@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or severe disability (modified Rankin Scale 3-6) at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.