NCT02846259

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,135

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

July 25, 2016

Last Update Submit

November 9, 2016

Conditions

Intracranial AneurysmCerebral Ischemia

Keywords

intracranial aneurysmcerebral ischemiaaspirin

Outcome Measures

Primary Outcomes (1)

  • Aneurysm rupture hemorrhage

    Aneurysm subarachnoid hemorrhage without trauma

    2 years during the follow-up period

Secondary Outcomes (3)

  • TIA

    2 years during the follow-up period

  • Aneurysm changing

    2 years during the follow-up period

  • dead

    2 years during the follow-up period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33953800DERIVED

  • 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: 33055274DERIVED

  • 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.

    PMID: 32878566DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Intracranial AneurysmBrain Ischemia

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Yong Cao

    Beijing Tiantan Hospital

    STUDY CHAIR

Central Study Contacts

Yong Cao, M.D.

CONTACT

010-67096523caoyong6@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)