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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | low-dose aspirin, 100 mg once daily, one 100mg tablet |
|
| standard protocol | No Intervention | standard of care, UIA management according to guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin Enteric-coated Tablets | Drug | low-dose aspirin 100 mg once daily (one 100mg tablet). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with aneurysm rupture | Individual components of the primary composite outcome, aneurysm rupture within 24 months after randomization. | 24 months |
| number of participants with aneurysm growth on repeated angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao, MD | Contact | +86 (010)59976510 | caoyong6@hotmail.com | |
| Fa Lin, MD | Contact | +86 13681107240 | 13681107240@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Cao, MD | Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33055274 | Result | Weng JC, Wang J, Du X, Li H, Jiao YM, Fu WL, Huo R, Yan ZH, Xu HY, Wang S, Cao Y, Zhao JZ; Small Unruptured Aneurysms Study Group. Safety of Aspirin Use in Patients With Stroke and Small Unruptured Aneurysms. Neurology. 2021 Jan 5;96(1):e19-e29. doi: 10.1212/WNL.0000000000010997. Epub 2020 Oct 14. | |
| 32878566 | Result |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants are assigned to two groups in parallel for the duration of the study.
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blinded-endpoint, PROBE design
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.
| 24 months |
| degree of C-reaction protein level change | change of inflammatory biomarkers, serum C-reaction protein level | 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. | 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) | 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 | 24 months |
| any systematic bleeding | the incidence of systematic bleeding | 24 months |
| all cause mortality | rate of overall mortality | 24 months |
| number of participants with de novo aneurysm on repeated angiography | development of de novo aneurysm on serial imaging | 24 months |
| adverse events (AEs)/serious adverse events (SAEs) | all adverse and serious adverse events pertaining to the aspirin | 24 months |
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | 102218 | China |
|
| Weng JC, Wang J, Li H, Jiao YM, Fu WL, Huo R, Yan ZH, Xu HY, Zhan J, Wang S, Du X, Cao Y, Zhao JZ; Small Unruptured Aneurysms Study Group. Aspirin and Growth of Small Unruptured Intracranial Aneurysm: Results of a Prospective Cohort Study. Stroke. 2020 Oct;51(10):3045-3054. doi: 10.1161/STROKEAHA.120.029967. Epub 2020 Sep 3. |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |