Clinical trial NCT02846259: The Clinical Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia
Official title: The Clinical Benefit and Risk of Oral Aspirin for Patients Who Have Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Cerebral Ischemia
Keywords: intracranial aneurysm
cerebral ischemia
aspirin
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
name: The Second Hospital of Hebei Medical University
name: Tianjin Medical University General Hospital
name: Tianjin Huanhu Hospital
First posted: 2016-07-27
Enrollment: 2135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Aneurysm rupture hemorrhage
timeFrame: 2 years during the follow-up period
Secondary outcomes:
measure: TIA
timeFrame: 2 years during the follow-up period
measure: Aneurysm changing
timeFrame: 2 years during the follow-up period
measure: dead
timeFrame: 2 years during the follow-up period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yong Cao
role: STUDY_CHAIR
References:
citation: 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.
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.
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.