Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
* Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin<br>* 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) .<br>|
| Active Comparator: 2<br> | Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Prevention Therapy