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

Intracranial Aneurysm Clinical Trial

— CBROAUNACCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02846259
• Other study ID #: SKW2016-13-aspirin
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: November 9, 2016
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, M.D.
• Phone: 010-67096523
• Email: caoyong6[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2135
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Intracranial Aneurysm
• Ischemia

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Chao Yang Hospital, Beijing Friendship Hospital, The Second Hospital of Hebei Medical University, Tianjin Huanhu Hospital, Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm rupture hemorrhage	Aneurysm subarachnoid hemorrhage without trauma	2 years during the follow-up period	No
Secondary	TIA		2 years during the follow-up period	No
Secondary	Aneurysm changing	the aneurysm becomes bigger, its form changes, becomes two or more	2 years during the follow-up period	No
Secondary	dead		2 years during the follow-up period	No