Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE
AT-SUITABLE
1 other identifier
interventional
824
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJune 18, 2023
June 1, 2023
2 years
May 22, 2023
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
number of participants with aneurysm rupture
24 months
number of participants with aneurysm growth on repeated angiography
24 months
degree of C-reaction protein level change
24 months
degree of cytokines level change
24 months
recurrent or new ischemic events
24 months
- +5 more secondary outcomes
Study Arms (2)
Aspirin
EXPERIMENTALlow-dose aspirin, 100 mg once daily, one 100mg tablet
standard protocol
NO INTERVENTIONstandard of care, UIA management according to guidelines.
Interventions
low-dose aspirin 100 mg once daily (one 100mg tablet).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Related Publications (2)
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.
PMID: 33055274RESULTWeng 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.
PMID: 32878566RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Cao, MD
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- blinded-endpoint, PROBE design
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- deputy director
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 18, 2023
Study Start
July 1, 2023
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
June 18, 2023
Record last verified: 2023-06