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ID

12417

Beschreibung

DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury; ODM derived from: https://clinicaltrials.gov/show/NCT02110303

Link

https://clinicaltrials.gov/show/NCT02110303

Stichworte

Versionen (1)
  1. 17.11.15 17.11.15 -
Hochgeladen am

17. November 2015

DOI

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Lizenz

Creative Commons BY 4.0
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    Eligibility Coronary Artery Disease NCT02110303

    Englisch

    Eligibility Coronary Artery Disease NCT02110303

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients aged 40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
    Beschreibung

    Multi vessel coronary artery disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1299432 (Multi vessel coronary artery disease)
    SNOMED
    371803003
    provision of informed consent prior to any study specific procedures
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    an acute coronary syndrome within the last 12 months
    Beschreibung

    Acute Coronary Syndrome

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0948089 (Acute Coronary Syndrome)
    SNOMED
    394659003
    an indication for dual anti-platelet therapy, such as drug eluting stent
    Beschreibung

    Anti-platelet drug therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2963157 (Anti-platelet drugs)
    inability to take aspirin
    Beschreibung

    Inability to take aspirin

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004057 (aspirin)
    SNOMED
    7947003
    receiving thienopyridine therapy such as clopidogrel or prasugrel
    Beschreibung

    Thienopyridine therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1120149 (thienopyridine)
    percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
    Beschreibung

    Percutaneous coronary intervention

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1532338 (Percutaneous Coronary Intervention)
    SNOMED
    415070008
    UMLS CUI [2]
    C0010055 (Coronary Artery Bypass Surgery)
    SNOMED
    67166004
    LOINC
    LA14276-2
    inability or unwilling to give informed consent
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    woman with child-bearing potential and who are breastfeeding will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant)
    Beschreibung

    Child-bearing potential

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1960468 (Female of child bearing age)
    SNOMED
    427504007
    known hypersensitivity to ticagrelor or one of its excipients
    Beschreibung

    Hypersensitivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C1999375 (ticagrelor)
    SNOMED
    698805004
    active pathological bleeding or bleeding diathesis
    Beschreibung

    Pathological bleeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    significant thrombocytopenia: <100 x 10^9 /l
    Beschreibung

    Thrombocytopenia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0040034 (Thrombocytopenia)
    SNOMED
    302215000
    history of intracranial haemorrhage
    Beschreibung

    Intracranial Hemorrhages

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151699 (Intracranial Hemorrhage)
    SNOMED
    1386000
    moderate to severe liver impairment (child's grade b or c)
    Beschreibung

    Liver impairment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    maintenance therapy with strong cytochrome p450 3a4 (cyp3a4) inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
    Beschreibung

    Therapy with strong cytochrome p450 3a4 (cyp3a4) inhibitors

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3830624 (CYP3A4 Inhibitor)
    major intercurrent illness or life expectancy <1 year
    Beschreibung

    Intercurrent illness

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3640977 (Significant Intercurrent Illness)
    UMLS CUI [2]
    C0023671 (Life Expectancy)
    renal dysfunction (egfr ≤30 ml/min/1.73 m2)
    Beschreibung

    Renal dysfunction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3279454 (Renal dysfunction)
    contraindication to iodinated contrast agents
    Beschreibung

    Contrast agents

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009924 (Contrast Media)
    SNOMED
    385420005
    LOINC
    LP266908-5
    planned coronary revascularization or major non-cardiac surgery in the next 12 months
    Beschreibung

    Coronary revascularisation or major non-cardiac surgery

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0877341 (Coronary revascularisation)
    UMLS CUI [2]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    maintenance therapy with simvastatin at doses greater than 40mg daily
    Beschreibung

    Simvastatin therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0074554 (simvastatin)
    SNOMED
    96304005
    receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.
    Beschreibung

    Receiving oral anticoagulants

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0354604 (oral anticoagulants)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Coronary Artery Disease NCT02110303

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Multi vessel coronary artery disease
    Item
    patients aged 40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
    boolean
    C1299432 (UMLS CUI [1])
    Informed Consent
    Item
    provision of informed consent prior to any study specific procedures
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Acute Coronary Syndrome
    Item
    an acute coronary syndrome within the last 12 months
    boolean
    C0948089 (UMLS CUI [1])
    Anti-platelet drug therapy
    Item
    an indication for dual anti-platelet therapy, such as drug eluting stent
    boolean
    C2963157 (UMLS CUI [1])
    Inability to take aspirin
    Item
    inability to take aspirin
    boolean
    C0004057 (UMLS CUI [1])
    Thienopyridine therapy
    Item
    receiving thienopyridine therapy such as clopidogrel or prasugrel
    boolean
    C1120149 (UMLS CUI [1])
    Percutaneous coronary intervention
    Item
    percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
    boolean
    C1532338 (UMLS CUI [1])
    C0010055 (UMLS CUI [2])
    Informed Consent
    Item
    inability or unwilling to give informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Child-bearing potential
    Item
    woman with child-bearing potential and who are breastfeeding will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant)
    boolean
    C1960468 (UMLS CUI [1])
    Hypersensitivity
    Item
    known hypersensitivity to ticagrelor or one of its excipients
    boolean
    C0020517 (UMLS CUI [1,1])
    C1999375 (UMLS CUI [1,2])
    Pathological bleeding
    Item
    active pathological bleeding or bleeding diathesis
    boolean
    C0005779 (UMLS CUI [1])
    Thrombocytopenia
    Item
    significant thrombocytopenia: <100 x 10^9 /l
    boolean
    C0040034 (UMLS CUI [1])
    Intracranial Hemorrhages
    Item
    history of intracranial haemorrhage
    boolean
    C0151699 (UMLS CUI [1])
    Liver impairment
    Item
    moderate to severe liver impairment (child's grade b or c)
    boolean
    C0023895 (UMLS CUI [1])
    Therapy with strong cytochrome p450 3a4 (cyp3a4) inhibitors
    Item
    maintenance therapy with strong cytochrome p450 3a4 (cyp3a4) inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
    boolean
    C3830624 (UMLS CUI [1])
    Intercurrent illness
    Item
    major intercurrent illness or life expectancy <1 year
    boolean
    C3640977 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    Renal dysfunction
    Item
    renal dysfunction (egfr ≤30 ml/min/1.73 m2)
    boolean
    C3279454 (UMLS CUI [1])
    Contrast agents
    Item
    contraindication to iodinated contrast agents
    boolean
    C0009924 (UMLS CUI [1])
    Coronary revascularisation or major non-cardiac surgery
    Item
    planned coronary revascularization or major non-cardiac surgery in the next 12 months
    boolean
    C0877341 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    Simvastatin therapy
    Item
    maintenance therapy with simvastatin at doses greater than 40mg daily
    boolean
    C0074554 (UMLS CUI [1])
    Receiving oral anticoagulants
    Item
    receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.
    boolean
    C0354604 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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