Intracranial AneurysmPhase 3AT-SUITABLENCT05907902
Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE
A Phase 3 study testing Aspirin Enteric-coated Tablets in people with Intracranial Aneurysm and Cerebrovascular Disease, run by Beijing Tiantan Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Cerebrovascular Disease
- What is being tested?
- Aspirin Enteric-coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2023to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Jun Kang, MD, junkang2015@163.com
Jun Kang, Kang
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Yi Guo, MD, ghuoyi@gmail.com
Yi Guo, MD
About this study
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
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.
Read the 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
- Being tested
- Aspirin Enteric-coated Tablets
- Keywords
- Intracranial Aneurysm, Cerebrovascular Diseases, ischemic cerebrovascular disease, aspirin, Randomized Controlled Trial
- Medical subject headings
- Intracranial Aneurysm, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin Enteric-coated TabletsDrug
Also called Bayer
low-dose aspirin 100 mg once daily (one 100mg tablet).
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | low-dose aspirin, 100 mg once daily, one 100mg tablet Receives: Drug: Aspirin Enteric-coated Tablets |
| standard protocol | No intervention | standard of care, UIA management according to guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (10)
number of participants with aneurysm rupture
Individual components of the primary composite outcome, aneurysm rupture within 24 months after randomization.
Measured: 24 months
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.
Measured: 24 months
degree of C-reaction protein level change
change of inflammatory biomarkers, serum C-reaction protein level
Measured: 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.
Measured: 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)
Measured: 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
Measured: 24 months
any systematic bleeding
the incidence of systematic bleeding
Measured: 24 months
all cause mortality
rate of overall mortality
Measured: 24 months
number of participants with de novo aneurysm on repeated angiography
development of de novo aneurysm on serial imaging
Measured: 24 months
adverse events (AEs)/serious adverse events (SAEs)
all adverse and serious adverse events pertaining to the aspirin
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
- Investigators
- Yong Cao, MD, Principal investigator, Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907902
- Sponsor's protocol ID
- 2022-I2M-C&T-B-114
- Acronym
- AT-SUITABLE
- Status last verified
- Jun 2023
- First submitted
- 22 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 33055274Weng 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.
PubMed 32878566
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05907902
- Acronym / sponsor ID
- AT-SUITABLE / 2022-I2M-C&T-B-114
- Conditions
- Intracranial Aneurysm, Cerebrovascular Disease
- Keywords
- Intracranial Aneurysm, Cerebrovascular Diseases, ischemic cerebrovascular disease, aspirin, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 824 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin Enteric-coated Tabletslow-dose aspirin, 100 mg once daily, one 100mg tablet |
| standard protocol | No intervention | –standard of care, UIA management according to guidelines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin Enteric-coated TabletsAlso: Bayerlow-dose aspirin 100 mg once daily (one 100mg tablet). | Drug | Aspirin |
Primary outcome
number of participants with aneurysm rupture or growth
Time frame: 24 months
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.
10 secondary outcomes
number of participants with aneurysm rupture
Time frame: 24 months
number of participants with aneurysm growth on repeated angiography
Time frame: 24 months
degree of C-reaction protein level change
Time frame: 24 months
degree of cytokines level change
Time frame: 24 months
recurrent or new ischemic events
Time frame: 24 months
any hemorrhagic stroke
Time frame: 24 months
any systematic bleeding
Time frame: 24 months
all cause mortality
Time frame: 24 months
number of participants with de novo aneurysm on repeated angiography
Time frame: 24 months
adverse events (AEs)/serious adverse events (SAEs)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Results publication: PubMed 33055274Weng 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 publication: PubMed 32878566Weng 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Cao, MD principal investigator
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin Enteric-coated Tablets in people with Intracranial Aneurysm and Cerebrovascular Disease, run by Beijing Tiantan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Cao, MD (+86 (010)59976510, caoyong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with aneurysm rupture or growth (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907902, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.