Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
NCT Number: NCT05941377
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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.
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]).
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.
Time frame: Within 24 months after randomization
UIA rupture events within 24 months after randomization
Time frame: Within 24 months after randomization
UIA growth events within 24 months after randomization
Time frame: At baseline and 24th month after randomization
Change in average Wall Enhancement Index (WEI) at baseline and 24th month
Beijing Tiantan Hospital
Other
Randomized Controlled Trial of Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth
Acronym: ChATIA-1
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.
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