ID

12876

Description

RIvaroxaban for Valvular Heart disease and atRial Fibrillation Trial -RIVER Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02303795

Link

https://clinicaltrials.gov/show/NCT02303795

Keywords

  1. 1/4/16 1/4/16 -
Uploaded on

January 4, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Valvular Heart Disease NCT02303795

    Eligibility Valvular Heart Disease NCT02303795

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. male and female patients aged >18 and < 80 years at time of inclusion
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
    Description

    Paroxysmal atrial fibrillation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0235480
    the patient must be able to give informed consent
    Description

    informed consent

    Data type

    boolean

    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
    Description

    cardiovascular disease; tumor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0027651
    active endocarditis
    Description

    endocarditis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0014118
    uncontrolled hypertension
    Description

    uncontrolled hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    2. hemorrhage risk-related criteria
    Description

    hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019080
    active internal bleeding
    Description

    internal bleeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1390214
    history of, or condition associated with, increased bleeding risk
    Description

    Medical History hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0019080
    3. concomitant conditions and therapies
    Description

    concomitant conditions

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0243086
    history of previous thromboembolism with high risk of bleeding:
    Description

    thromboembolism

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040038
    severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
    Description

    stroke

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
    Description

    thrombosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040053
    acute mi within the last 14 days prior to randomization
    Description

    Acute myocardial infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155626
    treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
    Description

    aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004057
    UMLS CUI [2]
    C1096021
    UMLS CUI [3]
    C0003211
    anemia
    Description

    anemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002871
    pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
    Description

    pregnancy; lactating

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    calculated creatinine clearance b30 ml/min
    Description

    creatinine clearance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    known significant liver disease or alanine aminotransferase n3× the upper limit of normal
    Description

    liver disease; alanine aminotransferase

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0001899
    previous participation in this study.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Valvular Heart Disease NCT02303795

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    1. male and female patients aged >18 and < 80 years at time of inclusion
    boolean
    C0001779 (UMLS CUI [1])
    Paroxysmal atrial fibrillation
    Item
    2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
    boolean
    C0235480 (UMLS CUI [1])
    informed consent
    Item
    the patient must be able to give informed consent
    boolean
    Item Group
    C0680251 (UMLS CUI)
    cardiovascular disease; tumor
    Item
    1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
    boolean
    C0007222 (UMLS CUI [1])
    C0027651 (UMLS CUI [2])
    endocarditis
    Item
    active endocarditis
    boolean
    C0014118 (UMLS CUI [1])
    uncontrolled hypertension
    Item
    uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    hemorrhage
    Item
    2. hemorrhage risk-related criteria
    boolean
    C0019080 (UMLS CUI [1])
    internal bleeding
    Item
    active internal bleeding
    boolean
    C1390214 (UMLS CUI [1])
    Medical History hemorrhage
    Item
    history of, or condition associated with, increased bleeding risk
    boolean
    C0262926 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    concomitant conditions
    Item
    3. concomitant conditions and therapies
    boolean
    C0243086 (UMLS CUI [1])
    thromboembolism
    Item
    history of previous thromboembolism with high risk of bleeding:
    boolean
    C0040038 (UMLS CUI [1])
    stroke
    Item
    severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
    boolean
    C0038454 (UMLS CUI [1])
    thrombosis
    Item
    acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
    boolean
    C0040053 (UMLS CUI [1])
    Acute myocardial infarction
    Item
    acute mi within the last 14 days prior to randomization
    boolean
    C0155626 (UMLS CUI [1])
    aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug
    Item
    treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
    boolean
    C0004057 (UMLS CUI [1])
    C1096021 (UMLS CUI [2])
    C0003211 (UMLS CUI [3])
    anemia
    Item
    anemia
    boolean
    C0002871 (UMLS CUI [1])
    pregnancy; lactating
    Item
    pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    creatinine clearance
    Item
    calculated creatinine clearance b30 ml/min
    boolean
    C0373595 (UMLS CUI [1])
    liver disease; alanine aminotransferase
    Item
    known significant liver disease or alanine aminotransferase n3× the upper limit of normal
    boolean
    C0023895 (UMLS CUI [1])
    C0001899 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    previous participation in this study.
    boolean
    C2348568 (UMLS CUI [1])

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