Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

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.

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 Investigator: Peking Union Medical College Hospital Other

Overall Clinical Trial Officials and Contacts

Liying Cui Principal Investigator Peking Union Medical College Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

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