Comparing blood pressure lowering methods for unruptured brain aneurysms in Chinese patients

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

This study tests whether a new way to lower blood pressure is safer and more effective than the usual method for Chinese patients with unruptured brain aneurysms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 520 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05941377 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to evaluate the safety and benefits of enhanced blood pressure lowering compared to standard methods in Chinese patients with unruptured intracranial aneurysms (UIA). Participants will be assigned to either the enhanced blood pressure lowering group or the standard blood pressure lowering group. The study seeks to provide high-level evidence for effective blood pressure management in neurosurgery for patients with UIA. The goal is to improve individual management strategies based on the findings.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients aged 18-75 with a history of hypertension and a single unruptured intracranial aneurysm measuring less than 7mm.

Not a fit: Patients with multiple aneurysms, those with aneurysms larger than 7mm, or those not of Chinese ethnicity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and outcomes for patients with unruptured intracranial aneurysms.

How similar studies have performed: Other studies have shown promising results with controlled hypotension in similar contexts, suggesting potential for success in this approach.

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);

Where this trial is running

Beijing, Beijing

• Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: shuo wang, M.D.

Conditions: Unruptured Intracranial Aneurysm