Official Title: “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 Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2010

Intervention(s) in this Clinical Trial

• 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) .
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Success Rate of standard medical management
  • Time Frame: 1 year after enrolled
    Safety Issue?: Yes

Secondary Measures

• Ischemic stroke
  • Time Frame: 1 year after enrolled
    Safety Issue?: Yes
• Non-fatal acute coronary syndrome
  • Time Frame: 1 year after enrolled
    Safety Issue?: Yes
• Transient Ischemic Attack
  • Time Frame: 1 year after enrolled
    Safety Issue?: Yes
• Hemorrhagic Stroke
  • Time Frame: 1 year after enrolled
    Safety Issue?: Yes
• All-cause Death
  • Time Frame: 1 year after enrolled
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Peking Union Medical College Hospital

Overall Clinical Trial Officials and Contacts

Liying Cui Principal Investigator Peking Union Medical College Hospital  

Overall Contact: Liying Cui 86-10-6529-6373 pumchcly@yahoo.com.cn

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664846

Study ID Number: 2006BAI01A10-1

ClinicalTrials.gov Identifier: NCT00664846

Health Authority: China: Ministry of Health