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Clinical Trials/NCT00664846
NCT00664846
Completed
Not Applicable

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

Peking Union Medical College Hospital46 sites in 1 country4,000 target enrollmentApril 2008
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ConditionsStroke
InterventionsAspirin / Clopidogrel, Atorvastatin / SimvastatinAsprin / Clopidogrel, Atorvastatin / Simvastatin
DrugsAspirin / Clopidogrel, Atorvastatin / SimvastatinAsprin / Clopidogrel, Atorvastatin / Simvastatin

Overview

Phase
Not Applicable
Intervention
Aspirin / Clopidogrel, Atorvastatin / Simvastatin
Conditions
Stroke
Sponsor
Peking Union Medical College Hospital
Enrollment
4000
Locations
46
Primary Endpoint
Success Rate of standard medical management
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
April 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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
  • •Unable to give informed consent.

Arms & Interventions

1

Intervention: Aspirin / Clopidogrel, Atorvastatin / Simvastatin

2

Intervention: Asprin / Clopidogrel, Atorvastatin / Simvastatin

Outcomes

Primary Outcomes

Success Rate of standard medical management

Time Frame: 1 year after enrolled

Secondary Outcomes

  • 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)

Study Sites (46)

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