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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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14 January 2019 |
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Main ID: |
ChiCTR1800020377 |
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Date of registration:
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2018-12-27 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aspirin in Moyamoya Disease
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Scientific title:
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The Clinical Benefit and Risk of Oral Aspirin for Moyamoya Disease |
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Date of first enrolment:
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2019-01-01 |
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Target sample size:
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Case series:300; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=34152 |
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Study type:
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Observational study |
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Study design:
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Case series
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Peicong Ge
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Address:
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119 South Fourth Ring Road West, Fengtai District, Beijing, China
100070
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Telephone:
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+86 15010545727 |
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Email:
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gepeicong@163.com |
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Affiliation:
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Beijing Tiantan Hospital, Capital Medical University |
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Name:
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Jizong Zhao
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Address:
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119 South Fourth Ring Road West, Fengtai District, Beijing, China
100070
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Telephone:
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+86 010-59976523 |
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Email:
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zhaojz205@163.com |
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Affiliation:
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Beijing Tiantan Hospital, Capital Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. has been diagnosed with moaymoya disease (using the MRA/DSA);
2. signed the informed consent.
Exclusion criteria: 1. has aneurysm, AVM, intracranial tumor, hydrocephalus or intracranial hemorrhage;
2. allergic to contrast medium.
Age minimum:
8
Age maximum:
60
Gender:
Both
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Health Condition(s) or Problem(s) studied
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moyamoya disease
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Intervention(s)
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Case series:Aspirin;
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Primary Outcome(s)
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Percentage of patients with the 2-year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) [ Time Frame: at 7days, 1months,3 months, 6 months, 12 months, 18 months, 24 months or end of trial];
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Secondary Outcome(s)
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Percentage of patients with the 2-year new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually. [ Time Frame:at 7days, 1months,3 months, 6 months, 12 months, 18 months, 24 months or end of trial ];Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 2 year follow-up [ Time Frame: at 7days, 1months,3 months, 6 months, 12 months, 18 months, 24 months or end of trial ];
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Source(s) of Monetary Support
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Beijing Municipal Administration of Hospitals' Mission Plan (SML20150501)
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Ethics review
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Status: Approved
Approval date: 01/11/2016
Contact:
Peijuan Ren
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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