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

Unruptured Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941377
• Other study ID #: KY2023-050-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: June 2024
• Source: Beijing Tiantan Hospital
• Contact: shuo wang, M.D.
• Phone: 13801180330
• Email: captain9858[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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);

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Intracranial Aneurysm
• Rupture
• Unruptured Intracranial Aneurysm

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Capital Medical University Affiliated Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Guangzhou Red Cross Hospital, Jiangnan University Medical Center, Shanghai Jiaotong University School of Medicine,Renji Hospital, The First Dongguan Affiliated Hospital of Guangdong Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UIA instability	The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms [sentinel headache and oculomotor paralysis]).	12 months
Primary	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.	12 months