0 Évaluations
ID

11727

Description

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

Lien

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

Mots-clés

Versions (1)
  1. 28/07/2015 28/07/2015 -
Téléchargé le

28 juillet 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Vascular Inflammation Acute Coronary Syndrome NCT00552188

    Anglais

    Eligibility Critera

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

    Inclusion Criteria

    Female patients must be of non-childbearing potential
    Description

    Female patients must be of non-childbearing potential

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0549206
    Recent acute coronary syndrome
    Description

    Recent acute coronary syndrome

    Type de données

    boolean

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

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

    Type de données

    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.
    Description

    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.

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0360714
    Exclusion Criteria
    Description

    Exclusion Criteria

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

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

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0035078
    Cirrhosis
    Description

    Cirrhosis

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0023890
    Recent hepatitis
    Description

    Recent hepatitis

    Type de données

    boolean

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

    Alanine aminotransferase (ALT) >1.5 x ULN

    Type de données

    boolean

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

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

    Type de données

    boolean

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

    Positive screening test for hepatitis C (by ELISA)

    Type de données

    boolean

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

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

    Type de données

    boolean

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

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

    Type de données

    boolean

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

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

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0010055
    Use of zileuton
    Description

    Use of zileuton

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0081408
    Use of montelukast
    Description

    Use of montelukast

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0298130
    Use of coumadin
    Description

    Use of coumadin

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0699129
    steroids
    Description

    steroids

    Type de données

    boolean

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

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

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0000970
    Allergy to contrast agents
    Description

    Allergy to contrast agents

    Type de données

    boolean

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

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

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C1532338
    Current atrial fibrillation
    Description

    Current atrial fibrillation

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0004238
    Current atrial flutter
    Description

    Current atrial flutter

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0004239
    Frequent premature ventricular contractions
    Description

    Frequent premature ventricular contractions

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C0151636
    Retour au début de la page

    Similar models

    Eligibility Critera

    1 Formulaires
    1. StudyEvent: ODM
      1. Eligibility Critera
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Retour au début de la page 

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