Clinical trial NCT05941377: 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
Overall status: RECRUITING
Phase: NA
Conditions: Unruptured Intracranial Aneurysm
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiaotong University School of Medicine,Renji Hospital
name: Guangzhou Red Cross Hospital
name: Jiangnan University Medical Center
name: The First Dongguan Affiliated Hospital of Guangdong Medical University
First posted: 2023-07-12
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75;
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:

1. Neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on;
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);

Primary outcomes:
measure: UIA instability
timeFrame: 24 months
measure: safety endpoint
timeFrame: 24 months
Secondary outcomes:
measure: UIA rupture events
timeFrame: In 24 months after the one-month observation of bearing test for target blood pressure
measure: UIA growth events
timeFrame: In 24 months after the one-month observation of bearing test for target blood pressure
measure: Change in average Wall Enhancement Index
timeFrame: At baseline and 24th month after the one-month observation of bearing test for target blood pressure
measure: UIA instability in an extended period
timeFrame: In 36 months after the one-month observation of bearing test for target blood pressure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Tiantan Hospital
state: Beijing
Study officials:
References: