Standard Medical Management in Secondary Prevention of Ischemic Stroke in China - Full Text View

Sponsor:	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.

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Simvastatin Clopidogrel Clopidogrel Bisulfate Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

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

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664846

Contacts

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

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator:

Liying Cui

Peking Union Medical College Hospital

More Information

No publications provided

Responsible Party:	Peking Union Medical College Hospital ( Liying Cui )
Study ID Numbers:	2006BAI01A10-1
Study First Received:	April 12, 2008
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00664846 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:

Stroke
Prevention Therapy

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Simvastatin
Antilipemic Agents
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on November 25, 2009