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Intracranial AneurysmCBROAUNACCINCT02846259

The Clinical Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia

An observational study of Intracranial Aneurysm and Cerebral Ischemia, run by Beijing Tiantan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The first purpose of this study is to find out the clinical benefit and risk of oral aspirin for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in patients in the real world. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm, Cerebral Ischemia
How many people
2,135 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2019
How long will I take part?
2 Years
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The investigators chose the patiens from the Tiantan hospital and other hospitals that participated in this study.The patients will all have unruptured intracranial aneurysm with the history of cerebral ischemia.

Who may be able to join

  • has the diagnosis of unruptured intracranial aneurysm (using the CTA/DSA,smaller than 7mm)
  • has the history of TIA or any other diseases of cerebral ischemia
  • older than 18 years old
  • sign the informed consent

Who cannot join

  • has the history of intracranial aneurysm rupture hemorrhage or has more than one aneurysm untreated
  • has a family history of intracranial aneurysm
  • has AVM，MMD, intracranial tumor, hydrocephalus or intracranial hemorrhage
  • refuse to sign the informed consent
  • allergic to contrast medium

Trial locations and contacts

1 site in 1 country.

Yong Cao, M.D. contact

010-67096523 ext. 100050

caoyong6@hotmail.com

China1 site, 1 recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Yong Cao, M.D., 010-67096523 ext. 100050, caoyong6@hotmail.com

    Yong Cao, M.D.

    Recruiting

Other trials in China

About this study

Official title: The Clinical Benefit and Risk of Oral Aspirin for Patients Who Have Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia

The first purpose of this study is to find out the clinical benefit and risk of oral aspirin for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in patients in the real world.

The second purpose of this study is to get the prediction model of aneurysm's rupture in patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia , and find out who is suitable for oral aspirin.

Read the detailed description

The investigators try to collect the information of the patients have unruptured intracranial aneurysm combined with cerebral ischemia when oral aspirin.The characteristics of this study are large sample, multi center and prospective.In the real world, more and more patients are checked out unruptured intracranial aneurysm combined with cerebral ischemia.The investigators can collect the information such as how they use aspirin (dose, frequency, duration of treatment), demographic information, past history, daily life habits, morphological characteristics of the aneurysm, how they use other antithrombotic drugs.The investigators will record whether the aneurysm ruptured and have hemorrhage, ischemic stroke, death, changes in the morphology of aneurysm, MRI permeability image index changes. Finally the investigators will get the clinical benefits and risks of using aspirin and build the prediction model of rupture and hemorrhage for aneurysm, find out who is suitable for oral aspirin.

Keywords
intracranial aneurysm, cerebral ischemia, aspirin
Medical subject headings
Intracranial Aneurysm, Brain Ischemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aneurysm rupture hemorrhage

    Aneurysm subarachnoid hemorrhage without trauma

    Measured: 2 years during the follow-up period

Secondary outcomes (3)

  1. TIA

    Measured: 2 years during the follow-up period

  2. Aneurysm changing

    the aneurysm becomes bigger, its form changes, becomes two or more

    Measured: 2 years during the follow-up period

  3. dead

    Measured: 2 years during the follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,135 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846259
Sponsor's protocol ID
SKW2016-13-aspirin
Acronym
CBROAUNACCI
Status last verified
Nov 2016
First submitted
25 Jul 2016
Last updated
10 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wang J, Weng J, Li H, Jiao Y, Fu W, Huo R, Yan Z, Xu H, Zhan J, Wang S, Du X, Cao Y, Zhao J. Atorvastatin and growth, rupture of small unruptured intracranial aneurysm: results of a prospective cohort study. Ther Adv Neurol Disord. 2021 Apr 9;14:1756286420987939. doi: 10.1177/1756286420987939. eCollection 2021.

    PubMed 33953800

  • 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 33055274

  • 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.

    PubMed 32878566

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm and Cerebral Ischemia, run by Beijing Tiantan Hospital at 1 site 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 4 inclusion and 5 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 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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, M.D. (010-67096523 ext. 100050, caoyong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aneurysm rupture hemorrhage (time frame: 2 years during the follow-up period). 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 NCT02846259, which also lists 3 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 10 Nov 2016.

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