ID

11727

Descripción

The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing. https://www.clinicaltrials.gov/ct2/show/NCT00552188

Link

https://www.clinicaltrials.gov/ct2/show/NCT00552188

Palabras clave

Versiones (1)
  1. 28/7/15 28/7/15 -
Subido en

28 de julio de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Vascular Inflammation Acute Coronary Syndrome NCT00552188

Inglés

Eligibility Critera

1 formularios  
  1. StudyEvent: ODM
    1. Eligibility Critera
Inclusion Criteria
Descripción

Inclusion Criteria

Female patients must be of non-childbearing potential
Descripción

Female patients must be of non-childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI-1
C0549206
Recent acute coronary syndrome
Descripción

Recent acute coronary syndrome

Tipo de datos

boolean

Alias
UMLS CUI-1
C0948089
Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
Descripción

Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6

Tipo de datos

boolean

Alias
UMLS CUI-1
C0751633
Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
Descripción

Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.

Tipo de datos

boolean

Alias
UMLS CUI-1
C0360714
Exclusion Criteria
Descripción

Exclusion Criteria

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
Descripción

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)

Tipo de datos

boolean

Alias
UMLS CUI-1
C0035078
Cirrhosis
Descripción

Cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI-1
C0023890
Recent hepatitis
Descripción

Recent hepatitis

Tipo de datos

boolean

Alias
UMLS CUI-1
C0019158
Alanine aminotransferase (ALT) >1.5 x ULN
Descripción

Alanine aminotransferase (ALT) >1.5 x ULN

Tipo de datos

boolean

Alias
UMLS CUI-1
C0201836
Positive screening test for hepatitis B (hepatitis B surface antigen)
Descripción

Positive screening test for hepatitis B (hepatitis B surface antigen)

Tipo de datos

boolean

Alias
UMLS CUI-1
C0019163
Positive screening test for hepatitis C (by ELISA)
Descripción

Positive screening test for hepatitis C (by ELISA)

Tipo de datos

boolean

Alias
UMLS CUI-1
C0019196
Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%
Descripción

Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%

Tipo de datos

boolean

Alias
UMLS CUI-1
C0011849
Heart failure defined by New York Heart Association Class III or IV
Descripción

Heart failure defined by New York Heart Association Class III or IV

Tipo de datos

boolean

Alias
UMLS CUI-1
C0018801
Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
Descripción

Coronary Artery Bypass Surgery (CABG) within 4 months of randomization

Tipo de datos

boolean

Alias
UMLS CUI-1
C0010055
Use of zileuton
Descripción

Use of zileuton

Tipo de datos

boolean

Alias
UMLS CUI-1
C0081408
Use of montelukast
Descripción

Use of montelukast

Tipo de datos

boolean

Alias
UMLS CUI-1
C0298130
Use of coumadin
Descripción

Use of coumadin

Tipo de datos

boolean

Alias
UMLS CUI-1
C0699129
steroids
Descripción

steroids

Tipo de datos

boolean

Alias
UMLS CUI-1
C0038317
Acetaminophen use in any form in the 7 days before enrollment at Visit 1
Descripción

Acetaminophen use in any form in the 7 days before enrollment at Visit 1

Tipo de datos

boolean

Alias
UMLS CUI-1
C0000970
Allergy to contrast agents
Descripción

Allergy to contrast agents

Tipo de datos

boolean

Alias
UMLS CUI-1
C0570562
Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
Descripción

Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months

Tipo de datos

boolean

Alias
UMLS CUI-1
C1532338
Current atrial fibrillation
Descripción

Current atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI-1
C0004238
Current atrial flutter
Descripción

Current atrial flutter

Tipo de datos

boolean

Alias
UMLS CUI-1
C0004239
Frequent premature ventricular contractions
Descripción

Frequent premature ventricular contractions

Tipo de datos

boolean

Alias
UMLS CUI-1
C0151636
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Similar models

Eligibility Critera

1 formularios
  1. StudyEvent: ODM
    1. Eligibility Critera
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
Pregnancy
Item
Female patients must be of non-childbearing potential
boolean
C0549206 (UMLS CUI-1)
Acute coronary syndrome
Item
Recent acute coronary syndrome
boolean
C0948089 (UMLS CUI-1)
Carotid artery plaque
Item
Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
boolean
C0751633 (UMLS CUI-1)
Statins
Item
Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
boolean
C0360714 (UMLS CUI-1)
Item Group
Exclusion Criteria
Kidney failure
Item
Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
boolean
C0035078 (UMLS CUI-1)
Liver Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI-1)
Hepatitis
Item
Recent hepatitis
boolean
C0019158 (UMLS CUI-1)
ALT
Item
Alanine aminotransferase (ALT) >1.5 x ULN
boolean
C0201836 (UMLS CUI-1)
Hepatitis B
Item
Positive screening test for hepatitis B (hepatitis B surface antigen)
boolean
C0019163 (UMLS CUI-1)
Hepatits C
Item
Positive screening test for hepatitis C (by ELISA)
boolean
C0019196 (UMLS CUI-1)
Diabetes mellitus
Item
Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%
boolean
C0011849 (UMLS CUI-1)
Heart failure
Item
Heart failure defined by New York Heart Association Class III or IV
boolean
C0018801 (UMLS CUI-1)
CABG
Item
Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
boolean
C0010055 (UMLS CUI-1)
zileuton
Item
Use of zileuton
boolean
C0081408 (UMLS CUI-1)
montelukast
Item
Use of montelukast
boolean
C0298130 (UMLS CUI-1)
coumadin
Item
Use of coumadin
boolean
C0699129 (UMLS CUI-1)
Steroids
Item
steroids
boolean
C0038317 (UMLS CUI-1)
Acetaminophen
Item
Acetaminophen use in any form in the 7 days before enrollment at Visit 1
boolean
C0000970 (UMLS CUI-1)
Allergy to contrast media
Item
Allergy to contrast agents
boolean
C0570562 (UMLS CUI-1)
PCI
Item
Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
boolean
C1532338 (UMLS CUI-1)
Atrial fibrillation
Item
Current atrial fibrillation
boolean
C0004238 (UMLS CUI-1)
Atrial flutter
Item
Current atrial flutter
boolean
C0004239 (UMLS CUI-1)
Premature ventricular contractions
Item
Frequent premature ventricular contractions
boolean
C0151636 (UMLS CUI-1)
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