Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)

This study has been completed.

Sponsor:

Information provided by:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT00664846

First received: April 12, 2008

Last updated: April 8, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2008

Last Updated Date

April 8, 2011

Start Date ^ICMJE

April 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Success Rate of standard medical management [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00664846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ischemic stroke [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
Non-fatal acute coronary syndrome [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
Transient Ischemic Attack [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
Hemorrhagic Stroke [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
All-cause Death [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Drug: Aspirin / 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) .
Drug: Asprin / 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

Study Arm (s)

Experimental: 1
Intervention: Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
Active Comparator: 2
Intervention: Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin

Publications *

Peng B, Zhu Y, Cui L, Ni J, Xu W, Zhou L, Yao M, Chen L, Wang J, Wang Y, Pu C; SMART Study Group. Standard medical management in secondary prevention of ischemic stroke in China (SMART). Int J Stroke. 2011 Oct;6(5):461-5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

4000

Completion Date

April 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00664846

Other Study ID Numbers ^ICMJE

2006BAI01A10-1

Has Data Monitoring Committee

Responsible Party

Liying Cui, Peking Union Medical College Hospital

Study Sponsor ^ICMJE

Peking Union Medical College Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Liying Cui

Peking Union Medical College Hospital

Information Provided By

Peking Union Medical College Hospital

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top