ID

43013

Description

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

Link

https://clinicaltrials.gov/show/NCT01747746

Keywords

  1. 8/6/19 8/6/19 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation NCT01747746

Eligibility Atrial Fibrillation NCT01747746

Inclusion Criteria
Description

Inclusion Criteria

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

Atrial Fibrillation Requirement Electric Countershock | Atrial Fibrillation Duration Unknown

Data type

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
Description

Exclusion Criteria

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

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

Data type

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)
Description

Renal dysfunction | Creatinine clearance measurement

Data type

boolean

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

Liver Dysfunction Child-Pugh Classification

Data type

boolean

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

Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779
active bleeding
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
hypersensitivity to rivaroxaban
Description

Hypersensitivity Rivaroxaban

Data type

boolean

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

Anticoagulants

Data type

boolean

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

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

Data type

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
Description

Intervention Reason for Treatment Interruption

Data type

boolean

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

Pregnancy

Data type

boolean

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

Age

Data type

boolean

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

Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181

Similar models

Eligibility Atrial Fibrillation NCT01747746

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial