Standard Medical Management in Secondary Prevention of Ischemic Stroke in China "SMART"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Atorvastatin (Lipitor┬«)Drug
    Other Names: Lipitor
    Intervention Desc: Competitive inhibitor of HMG-CoA reductase; lowers cholesterol and lipids
  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol
  • Aspirin / Clopidogrel, Atorvastatin / Simvastatin Drug
    Intervention Desc: 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) .
    ARM 1: Kind: Experimental
    Label: 1
  • Asprin / Clopidogrel, Atorvastatin / Simvastatin Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients are randomized to one of two groups: 1) standard medical management or 2) usual care group. All patients will undergo at least one year follow-up.

Outcomes

Type Measure Time Frame Safety Issue
Primary Success Rate of standard medical management
Secondary Ischemic stroke, non-fatal acute coronary syndrome, Transient Ischemic Attack, hemorrhagic stroke, all-cause death
Secondary Ischemic stroke 1 year after enrolled Yes
Secondary Non-fatal acute coronary syndrome 1 year after enrolled Yes
Secondary Transient Ischemic Attack 1 year after enrolled Yes
Secondary Hemorrhagic Stroke 1 year after enrolled Yes
Secondary All-cause Death 1 year after enrolled Yes

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