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Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00664846
Acronym
SMART
Enrollment
4000
Registered
2008-04-23
Start date
2008-04-30
Completion date
2011-04-30
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Prevention Therapy

Brief summary

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.

Interventions

DRUGAspirin / 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) .

DRUGAsprin / 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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Success Rate of standard medical management1 year after enrolled

Secondary

MeasureTime frame
Ischemic stroke1 year after enrolled
Non-fatal acute coronary syndrome1 year after enrolled
Transient Ischemic Attack1 year after enrolled
Hemorrhagic Stroke1 year after enrolled
All-cause Death1 year after enrolled

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026