Back to resultsAspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE (AT-SUITABLE)
Primary Purpose
Intracranial Aneurysm, Cerebrovascular Disease
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aspirin Enteric-coated Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm, Cerebrovascular Diseases, ischemic cerebrovascular disease, aspirin, Randomized Controlled Trial
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
Sites / Locations
- Beijing Tongren Hospital, Capital Medical University
- Beijing Tsinghua Changgung Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aspirin
standard protocol
Arm Description
low-dose aspirin, 100 mg once daily, one 100mg tablet
standard of care, UIA management according to guidelines.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
number of participants with aneurysm rupture
Individual components of the primary composite outcome, aneurysm rupture within 24 months after randomization.
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.
degree of C-reaction protein level change
change of inflammatory biomarkers, serum C-reaction protein level
degree of cytokines level change
change of inflammatory biomarkers, cytokines including TNF-α, IL-6, IL-8, IL-10, IL-1β, IL-2R etc.
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)
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
any systematic bleeding
the incidence of systematic bleeding
all cause mortality
rate of overall mortality
number of participants with de novo aneurysm on repeated angiography
development of de novo aneurysm on serial imaging
adverse events (AEs)/serious adverse events (SAEs)
all adverse and serious adverse events pertaining to the aspirin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05907902
Brief Title
Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE
Acronym
AT-SUITABLE
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Cerebrovascular Disease
Keywords
Intracranial Aneurysm, Cerebrovascular Diseases, ischemic cerebrovascular disease, aspirin, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to two groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Masking Description
blinded-endpoint, PROBE design
Allocation
Randomized
Enrollment
824 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
low-dose aspirin, 100 mg once daily, one 100mg tablet
Arm Title
standard protocol
Arm Type
No Intervention
Arm Description
standard of care, UIA management according to guidelines.
Intervention Type
Drug
Intervention Name(s)
Aspirin Enteric-coated Tablets
Other Intervention Name(s)
Bayer
Intervention Description
low-dose aspirin 100 mg once daily (one 100mg tablet).
Primary Outcome Measure Information:
Title
number of participants with aneurysm rupture or growth
Description
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
Secondary Outcome Measure Information:
Title
number of participants with aneurysm rupture
Description
Individual components of the primary composite outcome, aneurysm rupture within 24 months after randomization.
Time Frame
24 months
Title
number of participants with aneurysm growth on repeated angiography
Description
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
Title
degree of C-reaction protein level change
Description
change of inflammatory biomarkers, serum C-reaction protein level
Time Frame
24 months
Title
degree of cytokines level change
Description
change of inflammatory biomarkers, cytokines including TNF-α, IL-6, IL-8, IL-10, IL-1β, IL-2R etc.
Time Frame
24 months
Title
recurrent or new ischemic events
Description
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)
Time Frame
24 months
Title
any hemorrhagic stroke
Description
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
Title
any systematic bleeding
Description
the incidence of systematic bleeding
Time Frame
24 months
Title
all cause mortality
Description
rate of overall mortality
Time Frame
24 months
Title
number of participants with de novo aneurysm on repeated angiography
Description
development of de novo aneurysm on serial imaging
Time Frame
24 months
Title
adverse events (AEs)/serious adverse events (SAEs)
Description
all adverse and serious adverse events pertaining to the aspirin
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, MD
Phone
+86 (010)59976510
Email
caoyong6@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fa Lin, MD
Phone
+86 13681107240
Email
13681107240@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Cao, MD
Organizational Affiliation
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Kang, MD
Email
junkang2015@163.com
First Name & Middle Initial & Last Name & Degree
Jun Kang, Kang
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Guo, MD
Email
ghuoyi@gmail.com
First Name & Middle Initial & Last Name & Degree
Yi Guo, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Citations:
PubMed Identifier
33055274
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.
Results Reference
result
PubMed Identifier
32878566
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.
Results Reference
result
Learn more about this trial
Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE
We'll reach out to this number within 24 hrs