ID

12465

Descrição

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions. https://clinicaltrials.gov/ct2/show/NCT01241903

Link

https://clinicaltrials.gov/ct2/show/NCT01241903

Palavras-chave

Versões (2)
  1. 28/07/2015 28/07/2015 -
  2. 21/11/2015 21/11/2015 -
Transferido a

21 de novembro de 2015

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rosuvastatin Acute Coronary Syndrome NCT01241903

Inglês

Eligibility Critera

1 Formulários  
  1. StudyEvent: ODM
    1. Eligibility Critera
Inclusion Criteria
Descrição

Inclusion Criteria

Subjects must be between 18 and 80 years old.
Descrição

Subjects must be between 18 and 80 years old.

Tipo de dados

boolean

Alias
UMLS CUI-1
C0001779
Subjects must be willing and able to give informed consent
Descrição

Subjects must be willing and able to give informed consent

Tipo de dados

boolean

Alias
UMLS CUI-1
C0021430
A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
Descrição

A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.

Tipo de dados

boolean

Alias
UMLS CUI-1
C0700589
Subjects must have symptoms of acute coronary syndrome
Descrição

Subjects must have symptoms of acute coronary syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948089
Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)
Descrição

Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

Tipo de dados

boolean

Alias
UMLS CUI-1
C0360714
Exclusion criteria
Descrição

Exclusion criteria

Use of Crestor in the past 30 days
Descrição

Use of Crestor in the past 30 days

Tipo de dados

boolean

Alias
UMLS CUI-1
C1098080
GFR (estimated) <30 ml/min
Descrição

GFR (estimated) <30 ml/min

Tipo de dados

boolean

Alias
UMLS CUI-1
C0017654
Hemodialysis
Descrição

Hemodialysis

Tipo de dados

boolean

Alias
UMLS CUI-1
C0019004
History of liver failure
Descrição

History of liver failure

Tipo de dados

boolean

Alias
UMLS CUI-1
C0085605
Unexplained liver function abnormalities
Descrição

Unexplained liver function abnormalities

Tipo de dados

boolean

Alias
UMLS CUI-1
C0086565
Current or planned use of cyclosporine
Descrição

Current or planned use of cyclosporine

Tipo de dados

boolean

Alias
UMLS CUI-1
C0010592
Current or planned use of gemfibrozil
Descrição

Current or planned use of gemfibrozil

Tipo de dados

boolean

Alias
UMLS CUI-1
C0017245
Sepsis
Descrição

Sepsis

Tipo de dados

boolean

Alias
UMLS CUI-1
C0243026
Hypotension
Descrição

Hypotension

Tipo de dados

boolean

Alias
UMLS CUI-1
C0020649
Dehydration
Descrição

Dehydration

Tipo de dados

boolean

Alias
UMLS CUI-1
C0011175
Trauma
Descrição

Trauma

Tipo de dados

boolean

Alias
UMLS CUI-1
C0332677
Recent (within the last 2 weeks) or planned (in the next month) major surgery
Descrição

Recent (within the last 2 weeks) or planned (in the next month) major surgery

Tipo de dados

boolean

Alias
UMLS CUI-1
C0679637
HIV/AIDS with current of planned use of HIV protease inhibitors
Descrição

HIV/AIDS with current of planned use of HIV protease inhibitors

Tipo de dados

boolean

Alias
UMLS CUI-1
C0001175
Metabolic abnormality
Descrição

Metabolic abnormality

Tipo de dados

boolean

Alias
UMLS CUI-1
C0280606
electrolyte abnormality
Descrição

electrolyte abnormality

Tipo de dados

boolean

Alias
UMLS CUI-1
C0151613
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Similar models

Eligibility Critera

1 Formulários
  1. StudyEvent: ODM
    1. Eligibility Critera
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
Age
Item
Subjects must be between 18 and 80 years old.
boolean
C0001779 (UMLS CUI-1)
Informed consent
Item
Subjects must be willing and able to give informed consent
boolean
C0021430 (UMLS CUI-1)
Contraception
Item
A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
boolean
C0700589 (UMLS CUI-1)
Acute coronary syndrome
Item
Subjects must have symptoms of acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Statins
Item
Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)
boolean
C0360714 (UMLS CUI-1)
Item Group
Exclusion criteria
Rosuvastatin
Item
Use of Crestor in the past 30 days
boolean
C1098080 (UMLS CUI-1)
GFR
Item
GFR (estimated) <30 ml/min
boolean
C0017654 (UMLS CUI-1)
Hemodialysis
Item
Hemodialysis
boolean
C0019004 (UMLS CUI-1)
Liver failure
Item
History of liver failure
boolean
C0085605 (UMLS CUI-1)
Liver dysfunction
Item
Unexplained liver function abnormalities
boolean
C0086565 (UMLS CUI-1)
Cyclosporine
Item
Current or planned use of cyclosporine
boolean
C0010592 (UMLS CUI-1)
Gemfibrozil
Item
Current or planned use of gemfibrozil
boolean
C0017245 (UMLS CUI-1)
Sepsis
Item
Sepsis
boolean
C0243026 (UMLS CUI-1)
Hypotension
Item
Hypotension
boolean
C0020649 (UMLS CUI-1)
Dehydration
Item
Dehydration
boolean
C0011175 (UMLS CUI-1)
Major injury
Item
Trauma
boolean
C0332677 (UMLS CUI-1)
Major surgery
Item
Recent (within the last 2 weeks) or planned (in the next month) major surgery
boolean
C0679637 (UMLS CUI-1)
AIDS
Item
HIV/AIDS with current of planned use of HIV protease inhibitors
boolean
C0001175 (UMLS CUI-1)
Metabolic abnormality
Item
Metabolic abnormality
boolean
C0280606 (UMLS CUI-1)
electrolyte abnormality
Item
electrolyte abnormality
boolean
C0151613 (UMLS CUI-1)
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