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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Guangzhou Red Cross Hospital | OTHER |
| Jiangnan University Medical Center | UNKNOWN |
| Beijing Friendship Hospital |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard blood pressure lowering (SBPL) group | Experimental |
| |
| enhanced blood pressure lowering (EBPL) group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| UIA rupture events | UIA rupture events within 24 months after randomization | Within 24 months after randomization |
| UIA growth events | UIA growth events within 24 months after randomization |
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Inclusion criteria
Age 18-75.
Chinese ethnicity.
Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Tiantan Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41573399 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Binzhou People's Hospital | OTHER |
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| Within 24 months after randomization |
| Change in average Wall Enhancement Index | Change in average Wall Enhancement Index (WEI) at baseline and 24th month | At baseline and 24th month after randomization |