The management of small unruptured intracranial aneurysms (UIA) with ischemic cerebrovascular disease (ICVD) has been a very controversial topic in neurosurgery. Thus, we initiated a multicenter, prospective, randomized controlled trial (PROBE) design to elucidate in UIA patients with ICVD who do not qualify for preventive endovascular or neurosurgical intervention whether aspirin treatment decreases the risk of aneurysm growth and rupture.
Unruptured IAs are prevalent cerebrovascular disorders affecting approximately 3%-5% of the general population. The mortality rate associated with the rupture of UIAs stands at around 30%-40%, with over one-third of survivors experiencing significant neurological deficits. Currently, there are no established guidelines for the management of UIAs with ICVD. Our AIUIA trial is the inaugural randomized study investigating the potential of an anti-inflammatory strategy in mitigating aneurysm growth or rupture in patients with UIAs and ICVD who do not undergo preventive occlusion. It has the potential to provide level-A evidence that supports the aforementioned patient management approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
824
low-dose aspirin 100 mg once daily (one 100mg tablet).
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
number of participants with aneurysm rupture or growth
primary composite outcome involving aneurysm growth ((1) ≥1.0mm in at least 1 direction by identical imaging modalities, (2) ≥0.5 mm in 2 directions by identical imaging modalities, and (3) an indisputable change in aneurysm shape) or rupture on repeated magnetic resonance- or CT-angiography within 24 months after randomization.
Time frame: 24 months
number of participants with aneurysm rupture
Individual components of the primary composite outcome, aneurysm rupture within 24 months after randomization.
Time frame: 24 months
number of participants with aneurysm growth on repeated angiography
Individual components of the primary composite outcome, aneurysm growth ((1) ≥1.0mm in at least 1 direction by identical imaging modalities, (2) ≥0.5 mm in 2 directions by identical imaging modalities, and (3) an indisputable change in aneurysm shape) on repeated magnetic resonance- or CT-angiography or DSA within 24 months after randomization.
Time frame: 24 months
degree of C-reaction protein level change
change of inflammatory biomarkers, serum C-reaction protein level
Time frame: 24 months
degree of cytokines level change
change of inflammatory biomarkers, cytokines including TNF-α, IL-6, IL-8, IL-10, IL-1β, IL-2R etc.
Time frame: 24 months
recurrent or new ischemic events
the incidence of recurrent or new ischemic events (symptoms suggestive of ischemic stroke or transient ischemic attack (TIA) and confirmed by neurologists in the town/village clinic of their choice)
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Time frame: 24 months
any hemorrhagic stroke
the incidence of any hemorrhagic stroke, defined as the acute extravasation of blood into the brain parenchyma or subarachnoid space with associated neurological symptoms and a bleeding area far from the aneurysm location
Time frame: 24 months
any systematic bleeding
the incidence of systematic bleeding
Time frame: 24 months
all cause mortality
rate of overall mortality
Time frame: 24 months
number of participants with de novo aneurysm on repeated angiography
development of de novo aneurysm on serial imaging
Time frame: 24 months
adverse events (AEs)/serious adverse events (SAEs)
all adverse and serious adverse events pertaining to the aspirin
Time frame: 24 months