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Completed

NCT Number: NCT00664846

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Daxing District Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin / Clopidogrel, Atorvastatin / Simvastatin

Drug

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) .

Asprin / Clopidogrel, Atorvastatin / Simvastatin

Drug

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

Primary outcomes

  1. Success Rate of standard medical management

    Time frame: 1 year after enrolled

Secondary outcomes

  1. Ischemic stroke

    Time frame: 1 year after enrolled

  2. Non-fatal acute coronary syndrome

    Time frame: 1 year after enrolled

  3. Transient Ischemic Attack

    Time frame: 1 year after enrolled

  4. Hemorrhagic Stroke

    Time frame: 1 year after enrolled

  5. All-cause Death

    Time frame: 1 year after enrolled

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 23, 2008
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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