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Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)
This study has been completed.

First Received on April 12, 2008.   Last Updated on April 8, 2011   History of Changes
Sponsor: Peking Union Medical College Hospital
Information provided by: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00664846
  Purpose

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.


Condition Intervention
Stroke
 Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Simvastatin Clopidogrel Clopidogrel Bisulfate Atorvastatin Atorvastatin calcium
U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Success Rate of standard medical management [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemic stroke [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • Non-fatal acute coronary syndrome [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • Hemorrhagic Stroke [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • All-cause Death [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664846

  Show 46 Study Locations
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Liying Cui Peking Union Medical College Hospital
  More Information

No publications provided by Peking Union Medical College Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

Responsible Party: Liying Cui, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00664846     History of Changes
Other Study ID Numbers: 2006BAI01A10-1
Study First Received: April 12, 2008
Last Updated: April 8, 2011
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Stroke
Prevention Therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Clopidogrel
Simvastatin
Atorvastatin
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012



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