China Antihypertensive Trial for Intracranial Aneurysm (ChATIA-1)
June 24, 2026 updated by: Wang Shuo, Beijing Tiantan Hospital
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:
- 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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
577
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Capital Medical University Affiliated Beijing Tiantan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- 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
- 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
Exclusion criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: standard blood pressure lowering (SBPL) group
|
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.
|
|
Experimental: enhanced blood pressure lowering (EBPL) group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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]).
|
Within 24 months after randomization
|
|
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.
|
Within 24 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UIA rupture events
Time Frame: Within 24 months after randomization
|
UIA rupture events within 24 months after randomization
|
Within 24 months after randomization
|
|
UIA growth events
Time Frame: Within 24 months after randomization
|
UIA growth events within 24 months after randomization
|
Within 24 months after randomization
|
|
Change in average Wall Enhancement Index
Time Frame: At baseline and 24th month after randomization
|
Change in average Wall Enhancement Index (WEI) at baseline and 24th month
|
At baseline and 24th month after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2023
Primary Completion (Actual)
January 19, 2026
Study Completion (Actual)
January 19, 2026
Study Registration Dates
First Submitted
June 29, 2023
First Submitted That Met QC Criteria
July 4, 2023
First Posted (Actual)
July 12, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2026
Last Update Submitted That Met QC Criteria
June 24, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2023-050-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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