Clinical trial NCT00664846: Standard Medical Management in Secondary Prevention of Ischemic Stroke in China
Official title: Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Prevention Therapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of the study are to analyse the cross-section data of secondary stroke prevention in China and to carry out a standard medical management including medicine and interactive education program,and to evaluate the efficacy and safety of the standard medical management in secondary stroke prevention.


Eligibility criteria: Inclusion Criteria:

1. Ischemic cerebral infarction or TIA within 30 days.
2. Aged above 18 years old.
3. Hospitalized.
4. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
5. Stable clinical and neurological conditions.
6. A Modified Rankin score less than 4 at enrollment
7. Informed consent is obtained.

Exclusion Criteria:

Patients will be excluded from entry if any of the criteria listed below are met

1. Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure.
2. Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
3. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
4. A Modified Rankin score is more than 4
5. Concurrent participation in another clinical trial
6. Pregnant
7. Unable to give informed consent.

Primary outcomes:
measure: Success Rate of standard medical management
timeFrame: 1 year after enrolled
Secondary outcomes:
measure: Ischemic stroke
timeFrame: 1 year after enrolled
measure: Non-fatal acute coronary syndrome
timeFrame: 1 year after enrolled
measure: Transient Ischemic Attack
timeFrame: 1 year after enrolled
measure: Hemorrhagic Stroke
timeFrame: 1 year after enrolled
measure: All-cause Death
timeFrame: 1 year after enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hosptial
state: Beijing
city: Beijing
country: China
facility: China Pla General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: China Rehabilition Research Center
state: Beijing
city: Beijing
country: China
facility: General Hospital of Navy
state: Beijing
city: Beijing
country: China
facility: Luhe Hospital of Tongzhou Distict Beijing
state: Beijing
city: Beijing
country: China
facility: No 263 Hospital of Pla
state: Beijing
city: Beijing
country: China
facility: No 309 Hospital of Pla
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Pinggu County Hospital Beijing
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou First Municipal People'S Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-Sen Unversity
state: Guangdong
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Yutian
country: China
facility: Yutian County Hospital
state: Hebei
city: Zhangjiakou
country: China
facility: Hebei North University
state: Hebei
city: Harbin
country: China
facility: The First Hospital of Harbin Medical University
state: Helongjiang
city: Harbin
country: China
facility: The Second Hospital of Harbin Medical University
state: Helongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People'S Hospital
state: Henan
city: Wuhan
country: China
facility: The Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
state: Hunan
city: Baotou
country: China
facility: Inner Mongolia Baotou City Central Hospital
state: Inner Mongolia
city: Chifeng
country: China
facility: The Appurtenant Hospital of Chifeng University
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command
state: Jiangsu
city: Nanjing
country: China
facility: The Affiliated Drumtower Hospital of Nanjing University Medical School
state: Jiangsu
city: Changchun
country: China
facility: Jilin University
state: Jilin
city: Dalian
country: China
facility: The Third People'S Hospital of Dalian
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical Sciences University
state: Liaoning
city: Xining
country: China
facility: Qinghai Provincial People'S Hospital
state: Qinghai
city: Jinan
country: China
facility: Qilu Hospital of Shangdong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospitalof Shangdong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Center of Medical Sciences
state: Sichuan
city: Tianjin
country: China
facility: The General Hospital Under Tianjin Medical Sciences University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Uramuqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang uygur autonomous region
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Liying Cui
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao Y, Zhang M, Zhou L, Yao M, Peng B, Zhu Y, Ni J, Cui L. Consecutive Slides on Axial View Is More Effective Than Transversal Diameter to Differentiate Mechanisms of Single Subcortical Infarctions in the Lenticulostriate Artery Territory. Front Neurol. 2019 Apr 9;10:336. doi: 10.3389/fneur.2019.00336. eCollection 2019.
citation: Yao M, Ni J, Zhou L, Peng B, Zhu Y, Cui L; SMART investigators. Elevated Fasting Blood Glucose Is Predictive of Poor Outcome in Non-Diabetic Stroke Patients: A Sub-Group Analysis of SMART. PLoS One. 2016 Aug 5;11(8):e0160674. doi: 10.1371/journal.pone.0160674. eCollection 2016.
citation: Ni J, Yao M, Zhou L, Zhu Y, Peng B, Cui L; SMART Investigators. A guideline-based program may improve the outcome of stroke among illiterate patients. Int J Stroke. 2016 Apr;11(3):332-7. doi: 10.1177/1747493015626151. Epub 2016 Jan 18.
citation: Peng B, Ni J, Anderson CS, Zhu Y, Wang Y, Pu C, Wu J, Wang J, Zhou L, Yao M, He J, Shan G, Gao S, Xu W, Cui L; SMART Investigators. Implementation of a structured guideline-based program for the secondary prevention of ischemic stroke in China. Stroke. 2014 Feb;45(2):515-9. doi: 10.1161/STROKEAHA.113.001424. Epub 2014 Jan 2.
citation: Peng B, Zhu Y, Cui L, Ni J, Xu W, Zhou L, Yao M, Chen L, Wang J, Wang Y, Pu C; SMART Study Group. Standard medical management in secondary prevention of ischemic stroke in China (SMART). Int J Stroke. 2011 Oct;6(5):461-5. doi: 10.1111/j.1747-4949.2011.00648.x.