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| Sponsored by: |
Peking Union Medical College Hospital |
|---|---|
| Information provided by: | Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT00664846 |
Purpose
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 |
|---|---|
|
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 |
|---|---|
| 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) .
|
| 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
|
Eligibility| 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
Contacts and Locations| Contact: Liying Cui | 86-10-6529-6373 | pumchcly@yahoo.com.cn |
| Contact: Bin Peng | 86-10-6529-6371 | pengbin3@hotmail.com |
Show 46 Study Locations| Principal Investigator: | Liying Cui | Peking Union Medical College Hospital |
More Information
| Responsible Party: | Peking Union Medical College Hospital ( Liying Cui ) |
| Study ID Numbers: | 2006BAI01A10-1 |
| Study First Received: | April 12, 2008 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00664846 History of Changes |
| Health Authority: | China: Ministry of Health |
|
Stroke Prevention Therapy |
|
Antimetabolites Glipizide Cerebral Infarction Brain Diseases Cerebrovascular Disorders Nifedipine Hypoglycemic Agents Aspirin Neoplasm Metastasis Brain Ischemia Valsartan Indapamide Simvastatin Antilipemic Agents Stroke |
Metformin Vascular Diseases Central Nervous System Diseases Anticholesteremic Agents Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Amlodipine Acarbose Clopidogrel Benazepril Platelet Aggregation Inhibitors Brain Infarction Infarction Atorvastatin |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Cerebral Infarction Simvastatin Antilipemic Agents Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Therapeutic Uses Clopidogrel Brain Ischemia Platelet Aggregation Inhibitors Cardiovascular Diseases Brain Infarction Atorvastatin |