Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

Stroke Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664846
• Other study ID #: 2006BAI01A10-1
• Status: Completed
• Phase: N/A
• First received: April 12, 2008
• Last updated: April 8, 2011
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2011
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

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) .
• 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

Locations

Country	Name	City	State
China	Inner Mongolia Baotou City Central Hospital	Baotou	Inner Mongolia
China	Beijing Daxing District Hospital	Beijing	Beijing
China	Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University	Beijing	Beijing
China	Beijing Shijitan Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing
China	China Pla General Hospital	Beijing	Beijing
China	China Rehabilition Research Center	Beijing	Beijing
China	General Hospital of Navy	Beijing	Beijing
China	Luhe Hospital of Tongzhou Distict Beijing	Beijing	Beijing
China	No 263 Hospital of Pla	Beijing	Beijing
China	No 309 Hospital of Pla	Beijing	Beijing
China	Peking Union Medical College Hosptial	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Pinggu County Hospital Beijing	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Jilin University	Changchun	Jilin
China	Xiangya Hospital of Centre-South University	Changsha	Hunan
China	West China Center of Medical Sciences	Chengdu	Sichuan
China	The Appurtenant Hospital of Chifeng University	Chifeng	Inner Mongolia
China	Daping Hospital	Chongqing	Chongqing
China	Southwest Hospital	Chongqing	Chongqing
China	The Third People'S Hospital of Dalian	Dalian	Liaoning
China	Guangzhou First Municipal People'S Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital,Sun Yat-Sen Unversity	Guangzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Hospital of Harbin Medical University	Harbin	Helongjiang
China	The Second Hospital of Harbin Medical University	Harbin	Helongjiang
China	Qilu Hospital of Shangdong University	Jinan	Shandong
China	The Second Hospitalof Shangdong University	Jinan	Shandong
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu
China	The Affiliated Drumtower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical Sciences University	Shenyang	Liaoning
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The General Hospital Under Tianjin Medical Sciences University	Tianjin	Tianjin
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xinjiang Medical University	Uramuqi	Xinjiang uygur autonomous region
China	The Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Qinghai Provincial People'S Hospital	Xining	Qinghai
China	Yutian County Hospital	Yutian	Hebei
China	Hebei North University	Zhangjiakou	Hebei
China	Henan Provincial People'S Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate of standard medical management		1 year after enrolled	Yes
Secondary	Ischemic stroke		1 year after enrolled	Yes
Secondary	Non-fatal acute coronary syndrome		1 year after enrolled	Yes
Secondary	Transient Ischemic Attack		1 year after enrolled	Yes
Secondary	Hemorrhagic Stroke		1 year after enrolled	Yes
Secondary	All-cause Death		1 year after enrolled	Yes