ID

43013

Beschrijving

Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study; ODM derived from: https://clinicaltrials.gov/show/NCT01747746

Link

https://clinicaltrials.gov/show/NCT01747746

Trefwoorden

  1. 06-08-19 06-08-19 -
  2. 17-09-21 17-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT01747746

Eligibility Atrial Fibrillation NCT01747746

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with non-valvular atrial fibrillation requiring electrical cardioversion o atrial fibrillation of unknown duration
Beschrijving

Atrial Fibrillation Requirement Electric Countershock | Atrial Fibrillation Duration Unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013778
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0439673
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients requiring extended anticoagulation after cardioversion due to concomitant risk factors as defined by chads2 score ≥ 1
Beschrijving

Patient need for Anticoagulation Therapy Extended | Status post Electric Countershock | Risk factors CHADS2 score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0231448
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0013778
UMLS CUI [3,1]
C0035648
UMLS CUI [3,2]
C2585876
significant renal dysfunction (crcl <15ml/min)
Beschrijving

Renal dysfunction | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0373595
significant hepatic dysfunction (childs-pugh class b or c)
Beschrijving

Liver Dysfunction Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C4050412
history of coagulopathy
Beschrijving

Blood Coagulation Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
active bleeding
Beschrijving

Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
hypersensitivity to rivaroxaban
Beschrijving

Hypersensitivity Rivaroxaban

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1739768
concomitant use of anticoagulants
Beschrijving

Anticoagulants

Datatype

boolean

Alias
UMLS CUI [1]
C0003280
concomitant use of potent cyp3a4/p-gp inhibitors or inducers
Beschrijving

CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong | P-Glycoprotein Inhibitors Strong | P-Glycoprotein Inducers Strong

Datatype

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3500483
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3883353
UMLS CUI [4,2]
C0442821
interventions requiring interruption of therapy
Beschrijving

Intervention Reason for Treatment Interruption

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C3538832
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
age <18 y/o
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
history of gi bleed
Beschrijving

Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0017181

Similar models

Eligibility Atrial Fibrillation NCT01747746

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation Requirement Electric Countershock | Atrial Fibrillation Duration Unknown
Item
patients with non-valvular atrial fibrillation requiring electrical cardioversion o atrial fibrillation of unknown duration
boolean
C0004238 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013778 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Patient need for Anticoagulation Therapy Extended | Status post Electric Countershock | Risk factors CHADS2 score
Item
patients requiring extended anticoagulation after cardioversion due to concomitant risk factors as defined by chads2 score ≥ 1
boolean
C0686904 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0231448 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
C0035648 (UMLS CUI [3,1])
C2585876 (UMLS CUI [3,2])
Renal dysfunction | Creatinine clearance measurement
Item
significant renal dysfunction (crcl <15ml/min)
boolean
C3279454 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Liver Dysfunction Child-Pugh Classification
Item
significant hepatic dysfunction (childs-pugh class b or c)
boolean
C0086565 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Blood Coagulation Disorder
Item
history of coagulopathy
boolean
C0005779 (UMLS CUI [1])
Hemorrhage
Item
active bleeding
boolean
C0019080 (UMLS CUI [1])
Hypersensitivity Rivaroxaban
Item
hypersensitivity to rivaroxaban
boolean
C0020517 (UMLS CUI [1,1])
C1739768 (UMLS CUI [1,2])
Anticoagulants
Item
concomitant use of anticoagulants
boolean
C0003280 (UMLS CUI [1])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong | P-Glycoprotein Inhibitors Strong | P-Glycoprotein Inducers Strong
Item
concomitant use of potent cyp3a4/p-gp inhibitors or inducers
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3500483 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3883353 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
Intervention Reason for Treatment Interruption
Item
interventions requiring interruption of therapy
boolean
C0184661 (UMLS CUI [1,1])
C3538832 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Age
Item
age <18 y/o
boolean
C0001779 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
history of gi bleed
boolean
C0017181 (UMLS CUI [1])

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