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

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ClinicalTrials.gov Identifier: NCT02846259
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : November 10, 2016
Sponsor:
Collaborators:
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Beijing Friendship Hospital
The Second Hospital of Hebei Medical University
Tianjin Medical University General Hospital
Tianjin Huanhu Hospital
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

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.


Condition or disease
Intracranial Aneurysm Cerebral Ischemia

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2135 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Clinical Benefit and Risk of Oral Aspirin for Patients Who Have Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia
Study Start Date : January 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin




Primary Outcome Measures :
  1. Aneurysm rupture hemorrhage [ Time Frame: 2 years during the follow-up period ]
    Aneurysm subarachnoid hemorrhage without trauma


Secondary Outcome Measures :
  1. TIA [ Time Frame: 2 years during the follow-up period ]
  2. Aneurysm changing [ Time Frame: 2 years during the follow-up period ]
    the aneurysm becomes bigger, its form changes, becomes two or more

  3. dead [ Time Frame: 2 years during the follow-up period ]

Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846259


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

Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, M.D.    010-67096523 ext 100050    caoyong6@hotmail.com   
Principal Investigator: Yong Cao, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Beijing Friendship Hospital
The Second Hospital of Hebei Medical University
Tianjin Medical University General Hospital
Tianjin Huanhu Hospital
Investigators
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Study Chair: Yong Cao Beijing Tiantan Hospital

Additional Information:

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Responsible Party: Dr. Yong Cao, principal, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02846259     History of Changes
Other Study ID Numbers: SKW2016-13-aspirin
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Yong Cao, Beijing Tiantan Hospital:
intracranial aneurysm
cerebral ischemia
aspirin

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Ischemia
Cerebral Infarction
Brain Diseases
Brain Infarction
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Stroke
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors