Unruptured Intracranial AneurysmChATIA-1NCT05941377
China Antihypertensive Trial for Intracranial Aneurysm
A study testing blood pressure lowering in people with Unruptured Intracranial Aneurysm and Hypertension, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The goal of this randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA). The main questions it aims to answer are: To provide high-level evidence of the benefits and safety of controlled hypotension in patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Hypertension
- What is being tested?
- blood pressure lowering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2023to 19 Jan 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75.
- Chinese ethnicity.
- Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.
- Maximal size of UIA at largest dimension < 7 mm
- The morphology of UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/ multi-lobular UIA fundus)
- UIA receiving conservative treatment
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- History of primary hypertension (as diagnosed per standard of care)
- Systolic blood pressure (SBP) on 2 consecutive visits:
- SBP: 130-180 mmHg on 0 or 1 antihypertensive medication. SBP: 130-170 mmHg on up to 2 antihypertensive medications. SBP: 130-160 mmHg on up to 3 antihypertensive medications. SBP: 130-150 mmHg on up to 4 antihypertensive medications
- Good medication adherence (Morisky Medication Adherence Scale ≥6)
- Obtain informed consent from patient or legal representative
Who cannot join
- Patients with neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on.
- Patients with additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc.
- Patients with fusiform, dissecting, blister, traumatic, mycotic/ bacterial, myxomatous, and tumor-associated UIAs are excluded.
- Patients with history of polycystic kidney disease, rheumatic disease or autoimmune disease.
- Patients with family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage).
- Patients with known secondary cause of hypertension.
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- Patients with myocardial infarction, ischemic stroke, symptomatic heart failure during the past 3 months.
- Patients with a medical condition likely to limit survival to less than 2 years.
- Patients during pregnancy and perinatal period.
- Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
- Inability or unwillingness of patient or legal representative to give written informed consent.
- Participation in a concurrent interventional medical investigation or clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
About this study
Official title: Randomized Controlled Trial of Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth
The goal of this randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA).
The main questions it aims to answer are:
Read more
- To provide high-level evidence of the benefits and safety of controlled hypotension in patients with UIA.
- To provide evidence-based medical evidence for blood pressure control of patients with UIA in neurosurgery, and promote the progress of accurate individual management of patients. In this study, the main intervention is enhanced blood pressure lowering in patients with UIA.
All Patients will be randomly assigned to either the standard blood pressure lowering (SBPL) group or the enhanced blood pressure lowering (EBPL) group.
- Conditions
- Unruptured Intracranial Aneurysm, Hypertension
- Being tested
- blood pressure lowering
- Keywords
- Unruptured Intracranial Aneurysm, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure loweringOther
For EBPL group, patients are required to keep blood pressure at 100-120 mmHg. For SBPL group, patients are required to keep blood pressure <140 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| standard blood pressure lowering (SBPL) group | Experimental | Not described Receives: Other: blood pressure lowering |
| enhanced blood pressure lowering (EBPL) group | Experimental | Not described Receives: Other: blood pressure lowering |
What is being measured
The primary outcome is the main question the study is designed to answer.
UIA instability
The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms [sentinel headache and oculomotor paralysis]).
Measured: Within 24 months after randomization
safety endpoint
The safety endpoint is any ischemic cerebral or cardiac events. This includes one or more of the following: new or more frequent transient ischemic attack, new clinical or radiological ischemic stroke, angina, new myocardial infarction, or reperfusion therapy for myocardial infarction.
Measured: Within 24 months after randomization
Secondary outcomes (3)
UIA rupture events
UIA rupture events within 24 months after randomization
Measured: Within 24 months after randomization
UIA growth events
UIA growth events within 24 months after randomization
Measured: Within 24 months after randomization
Change in average Wall Enhancement Index
Change in average Wall Enhancement Index (WEI) at baseline and 24th month
Measured: At baseline and 24th month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Aug 2023
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
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 Unruptured Intracranial AneurysmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Guangzhou Red Cross Hospital, Jiangnan University Medical Center, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Beijing Anzhen Hospital, First Affiliated Hospital of Fujian Medical University, Binzhou People's Hospital
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941377
- Sponsor's protocol ID
- KY2023-050-02
- Acronym
- ChATIA-1
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng K, Mo S, Wen Z, Li J, Miao Z, Lu X, He H, Cao Y, Zhao B, Levitt MR, Chen L, Wang S, Zhu C, Liu Q. Enhanced versus standard blood pressure lowering on intracranial aneurysm rupture or growth (ChATIA-1 trial): protocol for a multi-centered, prospective, open-label randomized controlled trial. Front Neurol. 2026 Jan 7;16:1627936. doi: 10.3389/fneur.2025.1627936. eCollection 2025.
PubMed 41573399
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth
- ClinicalTrials.gov ID
- NCT05941377
- Acronym / sponsor ID
- ChATIA-1 / KY2023-050-02
- Conditions
- Unruptured Intracranial Aneurysm, Hypertension
- Keywords
- Unruptured Intracranial Aneurysm, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Guangzhou Red Cross Hospital, Jiangnan University Medical Center, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Beijing Anzhen Hospital, First Affiliated Hospital of Fujian Medical University, Binzhou People's Hospital
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 12 Jul 2023 (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 randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA).
The main questions it aims to answer are:
- To provide high-level evidence of the benefits and safety of controlled hypotension in patients with UIA.
- To provide evidence-based medical evidence for blood pressure control of patients with UIA in neurosurgery, and promote the progress of accurate individual management of patients. In this study, the main intervention is enhanced blood pressure lowering in patients with UIA.
All Patients will be randomly assigned to either the standard blood pressure lowering (SBPL) group or the enhanced blood pressure lowering (EBPL) group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard blood pressure lowering (SBPL) group | Experimental | Other: blood pressure lowering |
| enhanced blood pressure lowering (EBPL) group | Experimental | Other: blood pressure lowering |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75.
- Chinese ethnicity.
- Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.
- History of primary hypertension (as diagnosed per standard of care)
- Systolic blood pressure (SBP) on 2 consecutive visits:
Key exclusion criteria (12 listed)
- Patients with neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on.
- Patients with additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc.
- Patients with fusiform, dissecting, blister, traumatic, mycotic/ bacterial, myxomatous, and tumor-associated UIAs are excluded.
- Patients with history of polycystic kidney disease, rheumatic disease or autoimmune disease.
- Patients with family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage).
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 |
|---|---|---|
| blood pressure loweringFor EBPL group, patients are required to keep blood pressure at 100-120 mmHg. For SBPL group, patients are required to keep blood pressure <140 mmHg. | Other | enhanced blood pressure lowering (EBPL) group, standard blood pressure lowering (SBPL) group |
Primary outcome
UIA instability
Time frame: Within 24 months after randomization
The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms [sentinel headache and oculomotor paralysis]).
safety endpoint
Time frame: Within 24 months after randomization
The safety endpoint is any ischemic cerebral or cardiac events. This includes one or more of the following: new or more frequent transient ischemic attack, new clinical or radiological ischemic stroke, angina, new myocardial infarction, or reperfusion therapy for myocardial infarction.
3 secondary outcomes
UIA rupture events
Time frame: Within 24 months after randomization
UIA growth events
Time frame: Within 24 months after randomization
Change in average Wall Enhancement Index
Time frame: At baseline and 24th month after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 41573399Zheng K, Mo S, Wen Z, Li J, Miao Z, Lu X, He H, Cao Y, Zhao B, Levitt MR, Chen L, Wang S, Zhu C, Liu Q. Enhanced versus standard blood pressure lowering on intracranial aneurysm rupture or growth (ChATIA-1 trial): protocol for a multi-centered, prospective, open-label randomized controlled trial. Front Neurol. 2026 Jan 7;16:1627936. doi: 10.3389/fneur.2025.1627936. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure lowering in people with Unruptured Intracranial Aneurysm and Hypertension, run by Beijing Tiantan Hospital at 1 site in China.
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 11 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UIA instability (time frame: Within 24 months after randomization). The study lists 2 primary outcomes in all. 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 NCT05941377, 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 29 Jun 2026.