Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE

NCT ID: NCT05907902

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 824 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-07-01

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.

Conditions

Intracranial Aneurysm; Cerebrovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aspirin

low-dose aspirin, 100 mg once daily, one 100mg tablet

Group Type: EXPERIMENTAL

Aspirin Enteric-coated Tablets

Intervention Type: DRUG

low-dose aspirin 100 mg once daily (one 100mg tablet).

standard protocol

standard of care, UIA management according to guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aspirin Enteric-coated Tablets

low-dose aspirin 100 mg once daily (one 100mg tablet).

Intervention Type: DRUG

Other Intervention Names

Bayer

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Yong Cao

deputy director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Cao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University

Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yong Cao, MD

Role: CONTACT

caoyong6@hotmail.com

+86 (010)59976510

Fa Lin, MD

Role: CONTACT

13681107240@163.com

+86 13681107240

Facility Contacts

Jun Kang, MD

Role: primary

junkang2015@163.com

Yi Guo, MD

Role: primary

ghuoyi@gmail.com

References

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.

Reference Type: RESULT

PMID: 33055274 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32878566 (View on PubMed)

Other Identifiers

2022-I2M-C&T-B-114

Identifier Type: -

Identifier Source: org_study_id