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StrokeSMARTNCT00664846

Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

A study testing Aspirin / Clopidogrel, Atorvastatin / Simvastatin and Asprin / Clopidogrel, Atorvastatin / Simvastatin in people with Stroke, run by Peking Union Medical College Hospital at 46 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Aspirin / Clopidogrel, Atorvastatin / Simvastatin and Asprin / Clopidogrel, Atorvastatin / Simvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
46 sitesChina
Study dates
Apr 2008to Apr 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

China46 sites

  • Inner Mongolia Baotou City Central Hospital

    Baotou, Inner Mongolia

  • Peking Union Medical College Hosptial

    Beijing, Beijing Municipality, 100730

  • China Pla General Hospital

    Beijing, Beijing Municipality, 100853

  • Beijing Daxing District Hospital

    Beijing, Beijing Municipality

  • Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University

    Beijing, Beijing Municipality

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality

  • China Rehabilition Research Center

    Beijing, Beijing Municipality

  • General Hospital of Navy

    Beijing, Beijing Municipality

  • Luhe Hospital of Tongzhou Distict Beijing

    Beijing, Beijing Municipality

  • No 263 Hospital of Pla

    Beijing, Beijing Municipality

  • No 309 Hospital of Pla

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Pinggu County Hospital Beijing

    Beijing, Beijing Municipality

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality

  • Jilin University

    Changchun, Jilin

  • Xiangya Hospital of Centre-South University

    Changsha, Hunan

  • West China Center of Medical Sciences

    Chengdu, Sichuan

  • The Appurtenant Hospital of Chifeng University

    Chifeng, Inner Mongolia

  • Daping Hospital

    Chongqing, Chongqing Municipality

  • Southwest Hospital

    Chongqing, Chongqing Municipality

  • The Third People'S Hospital of Dalian

    Dalian, Liaoning

  • Guangzhou First Municipal People'S Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital,Sun Yat-Sen Unversity

    Guangzhou, Guangdong

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • The First Hospital of Harbin Medical University

    Harbin, Helongjiang

  • The Second Hospital of Harbin Medical University

    Harbin, Helongjiang

  • Qilu Hospital of Shangdong University

    Jinan, Shandong

  • The Second Hospitalof Shangdong University

    Jinan, Shandong

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nanjing General Hospital of Nanjing Military Command

    Nanjing, Jiangsu

  • The Affiliated Drumtower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality

  • The First Affiliated Hospital of China Medical Sciences University

    Shenyang, Liaoning

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The General Hospital Under Tianjin Medical Sciences University

    Tianjin, Tianjin Municipality

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality

  • First Affiliated Hospital of Xinjiang Medical University

    Uramuqi, Xinjiang Uygur Autonomous Region

  • The Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Qinghai Provincial People'S Hospital

    Xining, Qinghai

  • Yutian County Hospital

    Yutian, Hebei

  • Hebei North University

    Zhangjiakou, Hebei

  • Henan Provincial People'S Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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.

Conditions
Stroke
Being tested
Aspirin / Clopidogrel, Atorvastatin / Simvastatin, Asprin / Clopidogrel, Atorvastatin / Simvastatin
Keywords
Stroke, Prevention Therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin / Clopidogrel, Atorvastatin / SimvastatinDrug

    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 / SimvastatinDrug

    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 groups in NCT00664846
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
2Active comparatorNot described
Receives: Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success Rate of standard medical management

    Measured: 1 year after enrolled

Secondary outcomes (5)

  1. Ischemic stroke

    Measured: 1 year after enrolled

  2. Non-fatal acute coronary syndrome

    Measured: 1 year after enrolled

  3. Transient Ischemic Attack

    Measured: 1 year after enrolled

  4. Hemorrhagic Stroke

    Measured: 1 year after enrolled

  5. All-cause Death

    Measured: 1 year after enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2010
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00664846
Sponsor's protocol ID
2006BAI01A10-1
Acronym
SMART
Status last verified
Feb 2011
First submitted
12 Apr 2008
Last updated
11 Apr 2011
Results posted
No
Data monitoring committee
No

Publications

  • Cao Y, Zhang M, Zhou L, Yao M, Peng B, Zhu Y, Ni J, Cui L. Consecutive Slides on Axial View Is More Effective Than Transversal Diameter to Differentiate Mechanisms of Single Subcortical Infarctions in the Lenticulostriate Artery Territory. Front Neurol. 2019 Apr 9;10:336. doi: 10.3389/fneur.2019.00336. eCollection 2019.

    PubMed 31024430

  • Yao M, Ni J, Zhou L, Peng B, Zhu Y, Cui L; SMART investigators. Elevated Fasting Blood Glucose Is Predictive of Poor Outcome in Non-Diabetic Stroke Patients: A Sub-Group Analysis of SMART. PLoS One. 2016 Aug 5;11(8):e0160674. doi: 10.1371/journal.pone.0160674. eCollection 2016.

    PubMed 27494527

  • Ni J, Yao M, Zhou L, Zhu Y, Peng B, Cui L; SMART Investigators. A guideline-based program may improve the outcome of stroke among illiterate patients. Int J Stroke. 2016 Apr;11(3):332-7. doi: 10.1177/1747493015626151. Epub 2016 Jan 18.

    PubMed 26780948

  • Peng B, Ni J, Anderson CS, Zhu Y, Wang Y, Pu C, Wu J, Wang J, Zhou L, Yao M, He J, Shan G, Gao S, Xu W, Cui L; SMART Investigators. Implementation of a structured guideline-based program for the secondary prevention of ischemic stroke in China. Stroke. 2014 Feb;45(2):515-9. doi: 10.1161/STROKEAHA.113.001424. Epub 2014 Jan 2.

    PubMed 24385269

  • 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. doi: 10.1111/j.1747-4949.2011.00648.x.

    PubMed 21951412

Questions about this trial

What is this clinical trial studying?

A study testing Aspirin / Clopidogrel, Atorvastatin / Simvastatin and Asprin / Clopidogrel, Atorvastatin / Simvastatin in people with Stroke, run by Peking Union Medical College Hospital at 46 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success Rate of standard medical management (time frame: 1 year after enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00664846, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.

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