ID

31494

Descrição

Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA); ODM derived from: https://clinicaltrials.gov/show/NCT00623779

Link

https://clinicaltrials.gov/show/NCT00623779

Palavras-chave

Versões (1)
  1. 28/08/2018 28/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Persistent or Permanent Non-valvular Atrial Fibrillation NCT00623779

Inglês

Eligibility Persistent or Permanent Non-valvular Atrial Fibrillation NCT00623779

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
either one of the following risk factors is sufficient for inclusion (high risk patient)
Descrição

Risk factors Quantity | High risk Patient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C0030705
previous cerebral ischaemic attack (stroke or transient ischaemic attack (tia), >30 days prior to randomization)
Descrição

Ischemic attack cerebral Previous | Cerebrovascular accident Previous | Transient Ischemic Attack Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0745413
UMLS CUI [1,2]
C0006104
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0007787
UMLS CUI [3,2]
C0205156
previous systemic embolism or at least one of the following risk factors are needed for inclusion: age ≥75 years
Descrição

Embolism Systemic Previous | Risk factors Quantity | Age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013922
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0001779
symptomatic congestive heart failure
Descrição

Symptomatic congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0742758
impaired left ventricular systolic function
Descrição

LEFT VENTRICULAR SYSTOLIC DYSFUNCTION

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745679
diabetes mellitus; hypertension requiring anti-hypertensive treatment
Descrição

Diabetes Mellitus | Hypertensive disease Requirement Antihypertensive therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0585941
in addition to af the patient must be appropriate for but unable or unwilling to take vka therapy
Descrição

Atrial Fibrillation | Patients Appropriate Treatment with Vitamin K antagonist | Treatment with Vitamin K antagonist Unable | Treatment with Vitamin K antagonist Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1096489
UMLS CUI [3,1]
C1096489
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C1096489
UMLS CUI [4,2]
C0558080
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of a clinically significant valvular heart disease;; stroke or tia and/or systemic embolism within the previous 30 days prior to randomization
Descrição

Heart valve disease | Cerebrovascular accident | Transient Ischemic Attack | Embolism Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4,1]
C0013922
UMLS CUI [4,2]
C0205373
conditions associated with increased risk of major bleeding
Descrição

Condition Associated with Bleeding risk | Risk Increased Hemorrhage Major

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C3251812
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0019080
UMLS CUI [2,4]
C0205164
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Similar models

Eligibility Persistent or Permanent Non-valvular Atrial Fibrillation NCT00623779

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Risk factors Quantity | High risk Patient
Item
either one of the following risk factors is sufficient for inclusion (high risk patient)
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4319571 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
Ischemic attack cerebral Previous | Cerebrovascular accident Previous | Transient Ischemic Attack Previous
Item
previous cerebral ischaemic attack (stroke or transient ischaemic attack (tia), >30 days prior to randomization)
boolean
C0745413 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0007787 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Embolism Systemic Previous | Risk factors Quantity | Age
Item
previous systemic embolism or at least one of the following risk factors are needed for inclusion: age ≥75 years
boolean
C0013922 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Symptomatic congestive heart failure
Item
symptomatic congestive heart failure
boolean
C0742758 (UMLS CUI [1])
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
Item
impaired left ventricular systolic function
boolean
C0745679 (UMLS CUI [1])
Diabetes Mellitus | Hypertensive disease Requirement Antihypertensive therapy
Item
diabetes mellitus; hypertension requiring anti-hypertensive treatment
boolean
C0011849 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0585941 (UMLS CUI [2,3])
Atrial Fibrillation | Patients Appropriate Treatment with Vitamin K antagonist | Treatment with Vitamin K antagonist Unable | Treatment with Vitamin K antagonist Unwilling
Item
in addition to af the patient must be appropriate for but unable or unwilling to take vka therapy
boolean
C0004238 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1096489 (UMLS CUI [2,3])
C1096489 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C1096489 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Heart valve disease | Cerebrovascular accident | Transient Ischemic Attack | Embolism Systemic
Item
presence of a clinically significant valvular heart disease;; stroke or tia and/or systemic embolism within the previous 30 days prior to randomization
boolean
C0018824 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0013922 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
Condition Associated with Bleeding risk | Risk Increased Hemorrhage Major
Item
conditions associated with increased risk of major bleeding
boolean
C0348080 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C3251812 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])
C0205164 (UMLS CUI [2,4])
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