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Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth China Antihypertensive Trial for Intracranial Aneurysm (ChATIA-1)

Primary Purpose

Unruptured Intracranial Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
blood pressure lowering
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Unruptured Intracranial Aneurysm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75; Chinese ethnicity; History of hypertension (as diagnosed per standard of care) 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) ; Good medication adherence (Morisky Medication Adherence Scale ≥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 Maximal size of UIA at largest dimension < 7mm; 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: Neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on; Additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc; Fusiform, dissecting, blister, traumatic, mycotic/bacterial, myxomatous, and tumor-associated UIAs are excluded; History of polycystic kidney disease, rheumatic disease or autoimmune disease; Family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage);

Sites / Locations

  • Capital Medical University Affiliated Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard blood pressure lowering (SBPL) group

enhanced blood pressure lowering (EBPL) group

Arm Description

Outcomes

Primary Outcome Measures

UIA instability
The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms [sentinel headache and oculomotor paralysis]).
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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2023
Last Updated
July 4, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Shanghai Jiaotong University School of Medicine,Renji Hospital, Guangzhou Red Cross Hospital, Jiangnan University Medical Center, The First Dongguan Affiliated Hospital of Guangdong Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05941377
Brief Title
Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth China Antihypertensive Trial for Intracranial Aneurysm (ChATIA-1)
Official Title
Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth China Antihypertensive Trial for Intracranial Aneurysm (ChATIA-1)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Shanghai Jiaotong University School of Medicine,Renji Hospital, Guangzhou Red Cross Hospital, Jiangnan University Medical Center, The First Dongguan Affiliated Hospital of Guangdong Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Intracranial Aneurysm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard blood pressure lowering (SBPL) group
Arm Type
Experimental
Arm Title
enhanced blood pressure lowering (EBPL) group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood pressure lowering
Intervention Description
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.
Primary Outcome Measure Information:
Title
UIA instability
Description
The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms [sentinel headache and oculomotor paralysis]).
Time Frame
12 months
Title
safety endpoint
Description
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
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75; Chinese ethnicity; History of hypertension (as diagnosed per standard of care) 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) ; Good medication adherence (Morisky Medication Adherence Scale ≥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 Maximal size of UIA at largest dimension < 7mm; 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: Neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on; Additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc; Fusiform, dissecting, blister, traumatic, mycotic/bacterial, myxomatous, and tumor-associated UIAs are excluded; History of polycystic kidney disease, rheumatic disease or autoimmune disease; Family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shuo wang, M.D.
Phone
13801180330
Ext
+86
Email
captain9858@126.com
Facility Information:
Facility Name
Capital Medical University Affiliated Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUN WU, MD
Phone
+8613426322945
Email
wujunslf@126.com
First Name & Middle Initial & Last Name & Degree
Shuo Wang, MD

12. IPD Sharing Statement

Learn more about this trial

Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth China Antihypertensive Trial for Intracranial Aneurysm (ChATIA-1)

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