ID

12465

Description

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

Keywords

Versions (2)
  1. 7/28/15 7/28/15 -
  2. 11/21/15 11/21/15 -
Uploaded on

November 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Rosuvastatin Acute Coronary Syndrome NCT01241903

English

Eligibility Critera

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Critera
Inclusion Criteria
Description

Inclusion Criteria

Subjects must be between 18 and 80 years old.
Description

Subjects must be between 18 and 80 years old.

Data type

boolean

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

Subjects must be willing and able to give informed consent

Data type

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.
Description

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.

Data type

boolean

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

Subjects must have symptoms of acute coronary syndrome

Data type

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)
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0360714
Exclusion criteria
Description

Exclusion criteria

Use of Crestor in the past 30 days
Description

Use of Crestor in the past 30 days

Data type

boolean

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

GFR (estimated) <30 ml/min

Data type

boolean

Alias
UMLS CUI-1
C0017654
Hemodialysis
Description

Hemodialysis

Data type

boolean

Alias
UMLS CUI-1
C0019004
History of liver failure
Description

History of liver failure

Data type

boolean

Alias
UMLS CUI-1
C0085605
Unexplained liver function abnormalities
Description

Unexplained liver function abnormalities

Data type

boolean

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

Current or planned use of cyclosporine

Data type

boolean

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

Current or planned use of gemfibrozil

Data type

boolean

Alias
UMLS CUI-1
C0017245
Sepsis
Description

Sepsis

Data type

boolean

Alias
UMLS CUI-1
C0243026
Hypotension
Description

Hypotension

Data type

boolean

Alias
UMLS CUI-1
C0020649
Dehydration
Description

Dehydration

Data type

boolean

Alias
UMLS CUI-1
C0011175
Trauma
Description

Trauma

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI-1
C0001175
Metabolic abnormality
Description

Metabolic abnormality

Data type

boolean

Alias
UMLS CUI-1
C0280606
electrolyte abnormality
Description

electrolyte abnormality

Data type

boolean

Alias
UMLS CUI-1
C0151613
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Similar models

Eligibility Critera

1 forms
  1. StudyEvent: ODM
    1. Eligibility Critera
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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