Clinical trial NCT05907902: Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE
Official title: Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE (AT-SUITABLE): a Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Intracranial Aneurysm
Cerebrovascular Disease
Keywords: Intracranial Aneurysm
Cerebrovascular Diseases
ischemic cerebrovascular disease
aspirin
Randomized Controlled Trial
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients aged more than 18 and less than 80 years
* patients with UIAs \< 5 and ≥2 mm in the greatest diameter confirmed by MR angiography (MRA), computed tomography angiography (CTA) , or digital subtraction angiography (DSA)
* patients with either symptomatic ICVD (ischemic stroke or transient ischemic attack) or asymptomatic ICVD (clinically silent lacunar infarction identified on brain CT/MR imaging)
* last aneurysm imaging with either CTA or MRA or DSA within the last 3 months
* ability of the subject to understand character and individual consequences of clinical trial
* patients who provided written informed consent
* patients who consented to follow-up imaging with the same MR angiography or CT angiography modality

Exclusion Criteria:

* multiple aneurysms
* a history of intracranial aneurysm rupture-related hemorrhage
* a family history of intracranial aneurysm
* a history of vascular malformation (brain arteriovenous malformation, moyamoya disease, arteriovenous fistula, etc.), brain tumor, hydrocephalus, or hypertensive cerebral hemorrhage etc.
* MR contraindications (metallic implant, contrast medium allergy, claustrophobia, etc).
* a precondition modified Rankin Scale (mRS) score \> 2
* fusiform or daughter sac UIAs
* an allergy to aspirin
* other contraindications for aspirin not yet mentioned, in the dosage of 100 mg/day (e.g. bleeding disorders, gastric or intestinal ulcers, acute liver failure or kidney failure, severe heart failure, treatment with methotrexate in a dosage 15 mg/week or above)
* pregnancy and lactation
* participation in another clinical trial or observation period of competing trials
* residence in a rural area that prevented regular follow-up
* poor compliance

Primary outcomes:
measure: number of participants with aneurysm rupture or growth
timeFrame: 24 months
Secondary outcomes:
measure: number of participants with aneurysm rupture
timeFrame: 24 months
measure: number of participants with aneurysm growth on repeated angiography
timeFrame: 24 months
measure: degree of C-reaction protein level change
timeFrame: 24 months
measure: degree of cytokines level change
timeFrame: 24 months
measure: recurrent or new ischemic events
timeFrame: 24 months
measure: any hemorrhagic stroke
timeFrame: 24 months
measure: any systematic bleeding
timeFrame: 24 months
measure: all cause mortality
timeFrame: 24 months
measure: number of participants with de novo aneurysm on repeated angiography
timeFrame: 24 months
measure: adverse events (AEs)/serious adverse events (SAEs)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
affiliation: Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
name: Yong Cao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.