Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth China Antihypertensive Trial for Intracranial Aneurysm (ChATIA-1)
NCT ID: NCT05941377
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
520 participants
INTERVENTIONAL
2023-07-01
2026-07-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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standard blood pressure lowering (SBPL) group
blood 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 at 120-140 mmHg.
enhanced blood pressure lowering (EBPL) group
blood 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 at 120-140 mmHg.
Interventions
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blood 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 at 120-140 mmHg.
Eligibility Criteria
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Inclusion Criteria
2. Chinese ethnicity;
3. History of hypertension (as diagnosed per standard of care)
4. Under active treatment for hypertension: In the past one month (before enrollment), the blood pressure was controlled at the borderline statue (systolic pressure as 120-140 mmHg, diastolic pressure as 70-80 mmHg) ;
5. Good medication adherence (Morisky Medication Adherence Scale ≥6)
6. Single unruptured intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography within 1 year, and receiving conservative treatment
7. Maximal size of UIA at largest dimension \< 7mm;
8. UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/multi-lobular UIA fundus). The regular shape and aneurysm size will be evaluated by the central core lab (including a senior neuroradiologist and two neurosurgeons) based on the three-dimensional angiographic imaging;
Exclusion Criteria
2. Additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc;
3. Fusiform, dissecting, blister, traumatic, mycotic/bacterial, myxomatous, and tumor-associated UIAs are excluded;
4. History of polycystic kidney disease, rheumatic disease or autoimmune disease;
5. Family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage);
18 Years
75 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Guangzhou Red Cross Hospital
OTHER
Jiangnan University Medical Center
UNKNOWN
The First Dongguan Affiliated Hospital of Guangdong Medical University
UNKNOWN
Beijing Tiantan Hospital
OTHER
Responsible Party
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Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Locations
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Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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JUN WU, MD
Role: primary
Shuo Wang, MD
Role: backup
Other Identifiers
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KY2023-050-01
Identifier Type: -
Identifier Source: org_study_id