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Sponsored by: |
Peking Union Medical College Hospital |
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Information provided by: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT00664846 |
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.
Condition | Intervention |
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Stroke |
Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Standard Medical Management in Secondary Prevention of Ischemic Stroke in China. |
Estimated Enrollment: | 5000 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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) .
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2: Active Comparator |
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from entry if any of the criteria listed below are met
Contact: Liying Cui | 86-10-6529-6373 | pumchcly@yahoo.com.cn |
Contact: Bin Peng | 86-10-6529-6371 | pengbin3@hotmail.com |
Principal Investigator: | Liying Cui | Peking Union Medical College Hospital |
Responsible Party: | Peking Union Medical College Hospital ( Liying Cui ) |
Study ID Numbers: | 2006BAI01A10-1 |
Study First Received: | April 12, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00664846 |
Health Authority: | China: Ministry of Health |
Stroke Prevention Therapy |
Indapamide Glipizide Cerebral Infarction Simvastatin Metformin Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Nifedipine Cerebrovascular Disorders |
Amlodipine Acarbose Aspirin Clopidogrel Benazepril Neoplasm Metastasis Brain Ischemia Brain Infarction Infarction Valsartan Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Therapeutic Uses Hematologic Agents Nervous System Diseases |
Enzyme Inhibitors Platelet Aggregation Inhibitors Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |