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ISRCTN
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ISRCTN69559777
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ClinicalTrials.gov identifier
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Public title
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The ACROSS-China trial
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Scientific title
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Abnormal gluCose Regulation in patients with acute strOke acroSS China: a national multicentre prospective study
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Acronym
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ACROSS-China
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Serial number at source
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ACROSS-protocol 5
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Study hypothesis
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1. The prevalence of abnormal glucose regulation in patients with acute stroke is high
2. The distribution of stroke subtypes is different in the subtypes of the abnormal glucose regulation
3. Patients with or without abnormal glucose regulation will have different outcomes and recurrent risk of stroke
4. Different subtypes of abnormal glucose regulation have different effects on the outcomes and recurrence of stroke
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Lay summary
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Ethics approval
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Ethics approval received from the Tiantan Hospital Ethics Committee on the 28th August 2007
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Study design
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Multicentre observational, prospective, cohort study
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Countries of recruitment
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China
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Disease/condition/study domain
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Abnormal glucose regulation, acute stroke
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Participants - inclusion criteria
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1. Older than 18, either sex
2. Acute stroke: diagnosed on World Health Organization (WHO) criteria
3. Acute primary stroke patients within 14 days
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Participants - exclusion criteria
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1. Cerebral infarction without symptoms and signs
2. Non-cerebrovascular events
3. Stroke patients out of 14 days
4. Without the content of patients or their legal agents
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Anticipated start date
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01/01/2008
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Anticipated end date
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01/09/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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4000
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Interventions
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All participants without a history of diabetes mellitus will be identified as having abnormal glucose regulation or not by using the oral glucose tolerance test (OGTT) three days before discharge. The outcome and recurrence of stroke will be compared between the patients with and without abnormal glucose regulation respectively at three months and one year after the onset of stroke as below:
1. Modified Rankin Scale (mRS)
2. The times of stroke recurrence
The current therapy measures of abnormal glucose regulation in patients with acute stroke will be observed during in-hospital and follow-up.
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Primary outcome measure(s)
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The prevalence of abnormal glucose regulation after acute stroke in China, measured by OGTT before discharge.
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Secondary outcome measure(s)
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1. The distribution of stroke subtypes is different in the subtypes of the abnormal glucose regulation
2. The outcome and recurrence risk of stroke in patients with or without abnormal glucose regulation
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Sources of funding
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1. Bayer (China) Limited
2. 11th Five-year National Supporting Schedule of Science and Technology (China)
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Trial website
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Publications
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Contact name
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Prof
Yongjun
Wang
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Address
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Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Sponsor
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Bayer (China) Limited
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Address
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Corporate Communications
34/F Jing Guang Centre
Hu Jia Lou, Chaoyang District
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City/town
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Beijing
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Zip/Postcode
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100020
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Country
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China
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Sponsor website:
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http://www.bayerchina.com.cn
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Date applied
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05/01/2008
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Last edited
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29/05/2008
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Date ISRCTN assigned
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29/05/2008
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