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Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aspirin / Clopidogrel, Atorvastatin / Simvastatin
Asprin / Clopidogrel, Atorvastatin / Simvastatin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Prevention Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hosptial
  • China Pla General Hospital
  • Beijing Daxing District Hospital
  • Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
  • Beijing Shijitan Hospital
  • Beijing Tiantan Hospital
  • China Rehabilition Research Center
  • General Hospital of Navy
  • Luhe Hospital of Tongzhou Distict Beijing
  • No 263 Hospital of Pla
  • No 309 Hospital of Pla
  • Peking University Third Hospital
  • Pinggu County Hospital Beijing
  • Xuanwu Hospital Capital Medical University
  • Daping Hospital
  • Southwest Hospital
  • Guangzhou First Municipal People'S Hospital
  • The First Affiliated Hospital,Sun Yat-Sen Unversity
  • The First Hospital of Hebei Medical University
  • The Second Hospital of Hebei Medical University
  • The Third Hospital of Hebei Medical University
  • Yutian County Hospital
  • Hebei North University
  • The First Hospital of Harbin Medical University
  • The Second Hospital of Harbin Medical University
  • Henan Provincial People'S Hospital
  • The Zhongnan Hospital of Wuhan University
  • Xiangya Hospital of Centre-South University
  • Inner Mongolia Baotou City Central Hospital
  • The Appurtenant Hospital of Chifeng University
  • Jiangsu Province Hospital
  • Nanjing General Hospital of Nanjing Military Command
  • The Affiliated Drumtower Hospital of Nanjing University Medical School
  • Jilin University
  • The Third People'S Hospital of Dalian
  • The First Affiliated Hospital of China Medical Sciences University
  • Qinghai Provincial People'S Hospital
  • Qilu Hospital of Shangdong University
  • The Second Hospitalof Shangdong University
  • Huashan Hospital Fudan University
  • Shanghai Changzheng Hospital
  • West China Center of Medical Sciences
  • The General Hospital Under Tianjin Medical Sciences University
  • Tianjin Third Central Hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • The First Affiliated Hospital of College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Success Rate of standard medical management

Secondary Outcome Measures

Ischemic stroke
Non-fatal acute coronary syndrome
Transient Ischemic Attack
Hemorrhagic Stroke
All-cause Death

Full Information

First Posted
April 12, 2008
Last Updated
April 8, 2011
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00664846
Brief Title
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China
Acronym
SMART
Official Title
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Prevention Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin / Clopidogrel, Atorvastatin / Simvastatin
Intervention Description
Standard Medical Management,including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) .
Intervention Type
Drug
Intervention Name(s)
Asprin / Clopidogrel, Atorvastatin / Simvastatin
Intervention Description
Antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary
Primary Outcome Measure Information:
Title
Success Rate of standard medical management
Time Frame
1 year after enrolled
Secondary Outcome Measure Information:
Title
Ischemic stroke
Time Frame
1 year after enrolled
Title
Non-fatal acute coronary syndrome
Time Frame
1 year after enrolled
Title
Transient Ischemic Attack
Time Frame
1 year after enrolled
Title
Hemorrhagic Stroke
Time Frame
1 year after enrolled
Title
All-cause Death
Time Frame
1 year after enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic cerebral infarction or TIA within 30 days. Aged above 18 years old. Hospitalized. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases Stable clinical and neurological conditions. A Modified Rankin score less than 4 at enrollment Informed consent is obtained. Exclusion Criteria: Patients will be excluded from entry if any of the criteria listed below are met Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure. 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 Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed. A Modified Rankin score is more than 4 Concurrent participation in another clinical trial Pregnant Unable to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liying Cui
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
China Pla General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Beijing Daxing District Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
China Rehabilition Research Center
City
Beijing
State/Province
Beijing
Country
China
Facility Name
General Hospital of Navy
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Luhe Hospital of Tongzhou Distict Beijing
City
Beijing
State/Province
Beijing
Country
China
Facility Name
No 263 Hospital of Pla
City
Beijing
State/Province
Beijing
Country
China
Facility Name
No 309 Hospital of Pla
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Pinggu County Hospital Beijing
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Guangzhou First Municipal People'S Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital,Sun Yat-Sen Unversity
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Yutian County Hospital
City
Yutian
State/Province
Hebei
Country
China
Facility Name
Hebei North University
City
Zhangjiakou
State/Province
Hebei
Country
China
Facility Name
The First Hospital of Harbin Medical University
City
Harbin
State/Province
Helongjiang
Country
China
Facility Name
The Second Hospital of Harbin Medical University
City
Harbin
State/Province
Helongjiang
Country
China
Facility Name
Henan Provincial People'S Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital of Centre-South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Inner Mongolia Baotou City Central Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
The Appurtenant Hospital of Chifeng University
City
Chifeng
State/Province
Inner Mongolia
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Drumtower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Third People'S Hospital of Dalian
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The First Affiliated Hospital of China Medical Sciences University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Qinghai Provincial People'S Hospital
City
Xining
State/Province
Qinghai
Country
China
Facility Name
Qilu Hospital of Shangdong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Second Hospitalof Shangdong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Center of Medical Sciences
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The General Hospital Under Tianjin Medical Sciences University
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Uramuqi
State/Province
Xinjiang uygur autonomous region
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31024430
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.
Results Reference
derived
PubMed Identifier
27494527
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.
Results Reference
derived
PubMed Identifier
26780948
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.
Results Reference
derived
PubMed Identifier
24385269
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.
Results Reference
derived
PubMed Identifier
21951412
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.
Results Reference
derived

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Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

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