ID

44007

Description

Evaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00580216

Link

https://clinicaltrials.gov/show/NCT00580216

Keywords

Versions (2)
  1. 7/6/17 7/6/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00580216

English

Eligibility Atrial Fibrillation NCT00580216

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
non valvular atrial fibrillation (af)
Description

Atrial Fibrillation | Heart Valves Involvement Absent

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0018826
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0332197
indication for long-term vitamin-k antagonist (vka) therapy based on the presence of previous ischemic stroke, transient ischemic attack (tia) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.
Description

Indication for Vitamin K Antagonist Long-term | Ischemic stroke | Transient Ischemic Attack | EMBOLISM, SYSTEMIC | Risk factors Quantity | Hypertensive disease Requirement Pharmacotherapy | Impaired left ventricular function Moderate | Impaired left ventricular function Severe | Congestive heart failure | Age | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2267235
UMLS CUI [1,3]
C0443252
UMLS CUI [2]
C0948008
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0149876
UMLS CUI [5,1]
C0035648
UMLS CUI [5,2]
C1265611
UMLS CUI [6,1]
C0020538
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0013216
UMLS CUI [7,1]
C0242698
UMLS CUI [7,2]
C0205081
UMLS CUI [8,1]
C0242698
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0018802
UMLS CUI [10]
C0001779
UMLS CUI [11]
C0011849
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
indication for vka other than af
Description

Indication for Vitamin K Antagonist | Atrial Fibrillation Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2267235
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C2828389
stroke or tia within previous 5 days
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
transient af caused by a reversible disorder
Description

Atrial Fibrillation Transient | Cause Disease Reversible

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205374
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0205343
planned major surgery/trauma or cardioversion within 30 days
Description

Major surgery Planned | Electric Countershock Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0013778
UMLS CUI [2,2]
C1301732
inr > 3 at baseline
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
active bleeding or high risk of bleeding
Description

Hemorrhage | High risk of bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C4039184
uncontrolled hypertension
Description

uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
pregnancy or childbearing potential without proper contraceptive measures or breast feeding.
Description

Pregnancy | Childbearing Potential Contraceptive methods Lacking | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332268
UMLS CUI [3]
C0006147
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Similar models

Eligibility Atrial Fibrillation NCT00580216

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Heart Valves Involvement Absent
Item
non valvular atrial fibrillation (af)
boolean
C0004238 (UMLS CUI [1])
C0018826 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Indication for Vitamin K Antagonist Long-term | Ischemic stroke | Transient Ischemic Attack | EMBOLISM, SYSTEMIC | Risk factors Quantity | Hypertensive disease Requirement Pharmacotherapy | Impaired left ventricular function Moderate | Impaired left ventricular function Severe | Congestive heart failure | Age | Diabetes Mellitus
Item
indication for long-term vitamin-k antagonist (vka) therapy based on the presence of previous ischemic stroke, transient ischemic attack (tia) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.
boolean
C0392360 (UMLS CUI [1,1])
C2267235 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0948008 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0149876 (UMLS CUI [4])
C0035648 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0020538 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0013216 (UMLS CUI [6,3])
C0242698 (UMLS CUI [7,1])
C0205081 (UMLS CUI [7,2])
C0242698 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0018802 (UMLS CUI [9])
C0001779 (UMLS CUI [10])
C0011849 (UMLS CUI [11])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Indication for Vitamin K Antagonist | Atrial Fibrillation Excluded
Item
indication for vka other than af
boolean
C0392360 (UMLS CUI [1,1])
C2267235 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or tia within previous 5 days
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Atrial Fibrillation Transient | Cause Disease Reversible
Item
transient af caused by a reversible disorder
boolean
C0004238 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0205343 (UMLS CUI [2,3])
Major surgery Planned | Electric Countershock Planned
Item
planned major surgery/trauma or cardioversion within 30 days
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0013778 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
International Normalized Ratio
Item
inr > 3 at baseline
boolean
C0525032 (UMLS CUI [1])
Hemorrhage | High risk of bleeding
Item
active bleeding or high risk of bleeding
boolean
C0019080 (UMLS CUI [1])
C4039184 (UMLS CUI [2])
uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Lacking | Breast Feeding
Item
pregnancy or childbearing potential without proper contraceptive measures or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0006147 (UMLS CUI [3])
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