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CompletedNCT05941377ChATIA-1Updated Jun 29, 2026

China Antihypertensive Trial for Intracranial Aneurysm

An interventional study of blood pressure lowering in Unruptured Intracranial Aneurysm and Hypertension, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
577
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Unruptured Intracranial Aneurysm
  • Hypertension

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Keywords

  • Unruptured Intracranial Aneurysm
  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 577 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-75.
  2. Chinese ethnicity.
  3. Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.

    1. Maximal size of UIA at largest dimension \< 7 mm
    2. The morphology of UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/ multi-lobular UIA fundus)
    3. UIA receiving conservative treatment
  4. History of primary hypertension (as diagnosed per standard of care)
  5. 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

  6. Good medication adherence (Morisky Medication Adherence Scale ≥6)
  7. Obtain informed consent from patient or legal representative

Exclusion criteria

Exclusion criteria:

  1. Patients with neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on.
  2. Patients with additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc.
  3. Patients with fusiform, dissecting, blister, traumatic, mycotic/ bacterial, myxomatous, and tumor-associated UIAs are excluded.
  4. Patients with history of polycystic kidney disease, rheumatic disease or autoimmune disease.
  5. Patients with family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage).
  6. Patients with known secondary cause of hypertension.
  7. Patients with myocardial infarction, ischemic stroke, symptomatic heart failure during the past 3 months.
  8. Patients with a medical condition likely to limit survival to less than 2 years.
  9. Patients during pregnancy and perinatal period.
  10. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
  11. Inability or unwillingness of patient or legal representative to give written informed consent.
  12. Participation in a concurrent interventional medical investigation or clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
577 participants (actual)

Study arms

  • Experimental
    standard blood pressure lowering (SBPL) group

    Other: blood pressure lowering

  • Experimental
    enhanced blood pressure lowering (EBPL) group

    Other: blood pressure lowering

Interventions

  • Otherblood pressure lowering

    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.

06

What researchers measure

Primary outcomes

  1. UIA instability

    The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms \[sentinel headache and oculomotor paralysis\]).

    Time frame: Within 24 months after randomization

  2. 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.

    Time frame: Within 24 months after randomization

Secondary outcomes

  1. UIA rupture events

    UIA rupture events within 24 months after randomization

    Time frame: Within 24 months after randomization

  2. UIA growth events

    UIA growth events within 24 months after randomization

    Time frame: Within 24 months after randomization

  3. Change in average Wall Enhancement Index

    Change in average Wall Enhancement Index (WEI) at baseline and 24th month

    Time frame: At baseline and 24th month after randomization

07

Study locations

1 site
  • Capital Medical University Affiliated Beijing Tiantan Hospital
    Beijing, Beijing Municipality, China
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05941377
Lead sponsor
Beijing Tiantan Hospital
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
Wang Shuo (Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan Hospital) — Principal investigator
First posted
Jul 12, 2023
Start date
Aug 5, 2023
Primary completion
Jan 19, 2026
Completion
Jan 19, 2026
Last update
Jun 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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