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

Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin; Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin

• Study Type: Interventional
• Enrollment (Anticipated): 4000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100853
      • China PLA General Hospital
    • Beijing, Beijing, China
      • Beijing Shijitan Hospital
    • Beijing, Beijing, China
      • Xuanwu Hospital Capital Medical University
    • Beijing, Beijing, China
      • Beijing Tiantan Hospital
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hosptial
    • Beijing, Beijing, China
      • Beijing Daxing District Hospital
    • Beijing, Beijing, China
      • Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
    • Beijing, Beijing, China
      • China Rehabilition Research Center
    • Beijing, Beijing, China
      • General Hospital of Navy
    • Beijing, Beijing, China
      • Luhe Hospital of Tongzhou Distict Beijing
    • Beijing, Beijing, China
      • No 263 Hospital of Pla
    • Beijing, Beijing, China
      • No 309 Hospital of Pla
    • Beijing, Beijing, China
      • Pinggu County Hospital Beijing
  • Chongqing
    • Chongqing, Chongqing, China
      • Daping Hospital
    • Chongqing, Chongqing, China
      • Southwest Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou First Municipal People's Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital,Sun Yat-Sen Unversity
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Third Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
    • Yutian, Hebei, China
      • Yutian County Hospital
    • Zhangjiakou, Hebei, China
      • Hebei North University
  • Helongjiang
    • Harbin, Helongjiang, China
      • The First Hospital of Harbin Medical University
    • Harbin, Helongjiang, China
      • The Second Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • The Zhongnan Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Centre-South University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Inner Mongolia Baotou City Central Hospital
    • Chifeng, Inner Mongolia, China
      • The Appurtenant Hospital of Chifeng University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China
      • Nanjing General Hospital of Nanjing Military Command
    • Nanjing, Jiangsu, China
      • The Affiliated Drumtower Hospital of Nanjing University Medical School
  • Jilin
    • Changchun, Jilin, China
      • Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • The Third People'S Hospital of Dalian
    • Shenyang, Liaoning, China
      • The First Affiliated Hospital of China Medical Sciences University
  • Qinghai
    • Xining, Qinghai, China
      • Qinghai Provincial People's Hospital
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shangdong University
    • Jinan, Shandong, China
      • The Second Hospitalof Shangdong University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changzheng Hospital
    • Shanghai, Shanghai, China
      • Huashan Hospital Fudan University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Center of Medical Sciences
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Third Central Hospital
    • Tianjin, Tianjin, China
      • The General Hospital Under Tianjin Medical Sciences University
  • Xinjiang uygur autonomous region
    • Uramuqi, Xinjiang uygur autonomous region, China
      • First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin; 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) .
Active Comparator: 2	Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success Rate of standard medical management	1 year after enrolled

Secondary Outcome Measures

Outcome Measure	Time Frame
Ischemic stroke	1 year after enrolled
Non-fatal acute coronary syndrome	1 year after enrolled
Transient Ischemic Attack	1 year after enrolled
Hemorrhagic Stroke	1 year after enrolled
All-cause Death	1 year after enrolled

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: April 12, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Estimate): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 8, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Stroke; Prevention Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Aspirin; Atorvastatin; Clopidogrel; Simvastatin
• Other Study ID Numbers: 2006BAI01A10-1