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Standard Medical Management i...

Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

Last Updated: 2011-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Aspirin / Clopidogrel, Atorvastatin / Simvastatin

Intervention Type 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) .

2

Group Type ACTIVE_COMPARATOR

Asprin / Clopidogrel, Atorvastatin / Simvastatin

Intervention Type 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

Interventions

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Aspirin / Clopidogrel, Atorvastatin / Simvastatin

Intervention Type DRUG

Asprin / Clopidogrel, Atorvastatin / Simvastatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Peking Union Medical College Hospital

Principal Investigators

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Liying Cui

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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