NCT05941377

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
577

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

August 5, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2026

Completed
Last Updated

June 29, 2026

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

June 29, 2023

Last Update Submit

June 24, 2026

Conditions

HypertensionUnruptured Intracranial Aneurysm

Keywords

Unruptured Intracranial AneurysmHypertension

Outcome Measures

Primary Outcomes (2)

  • UIA instability

    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

    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 Outcomes (3)

  • UIA rupture events

    Within 24 months after randomization

  • UIA growth events

    Within 24 months after randomization

  • Change in average Wall Enhancement Index

    At baseline and 24th month after randomization

Study Arms (2)

standard blood pressure lowering (SBPL) group

EXPERIMENTAL
Other: blood pressure lowering

enhanced blood pressure lowering (EBPL) group

EXPERIMENTAL
Other: blood pressure lowering

Interventions

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.

enhanced blood pressure lowering (EBPL) groupstandard blood pressure lowering (SBPL) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 41573399DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 12, 2023

Study Start

August 5, 2023

Primary Completion

January 19, 2026

Study Completion

January 19, 2026

Last Updated

June 29, 2026

Record last verified: 2025-12

Locations

CN(1)