Skip to main content
OpenTrials
Completed

NCT Number: NCT05941377

China Antihypertensive Trial for Intracranial Aneurysm

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood pressure lowering

Other

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.

Primary outcomes

  1. 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]).

  2. 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.

Secondary outcomes

  1. UIA rupture events

    Time frame: Within 24 months after randomization

    UIA rupture events within 24 months after randomization

  2. UIA growth events

    Time frame: Within 24 months after randomization

    UIA growth events within 24 months after randomization

  3. 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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital
  • Binzhou People's Hospital
  • First Affiliated Hospital of Fujian Medical University
  • Guangzhou Red Cross Hospital
  • Jiangnan University Medical Center
  • RenJi Hospital

Registry information

Official study title

Randomized Controlled Trial of Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth

Acronym: ChATIA-1

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.