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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Capital Medical University Affiliated Beijing Tiantan Hospital
  Beijing, Beijing, China Recruiting

Study contacts

• Study coordinator: shuo wang, M.D.
• Email: captain9858@126.com
• Phone: 13801180330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.