ID

12760

Description

Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS); ODM derived from: https://clinicaltrials.gov/show/NCT00070655

Link

https://clinicaltrials.gov/show/NCT00070655

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00070655

English

Eligibility Atrial Fibrillation NCT00070655

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecg-documented atrial fibrillation (af) and an indication for long-term vitamin k antagonist (vka) therapy based on the presence of at least one of the following risk factors:
Description

atrial fibrillation: vitamin k antagonist therapy

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C1096489
1. previous ischemic stroke, transient ischemic attack (tia) or systemic embolism
Description

ischemic stroke; systemic embolism

Data type

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0149876
2. hypertension requiring drug treatment
Description

hypertension treatment required

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332121
3. left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
Description

left ventricular ejection fraction; symptomatic congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0742758
4. age >75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. age between 65-75 years plus diabetes mellitus, or
Description

age; Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011849
6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (mi) or angina pectoris)
Description

age; symptomatic coronary artery disease

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1956346
written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
legal lower age limitations (country specific)
Description

age Limitation

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0449295
indication for vka other than af, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
Description

vitamin k antagonist therapy; Heart Valve Prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C1096489
UMLS CUI [2]
C0018825
transient af caused by a reversible disorder
Description

atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
active bleeding or high risk of bleeding
Description

active bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0019080
recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
participation in another pharmacotherapeutic study within the prior 30 days
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
creatinine clearance <10 ml/min, severe hepatic disease, or bacterial endocarditis
Description

creatinine clearance; hepatic disease; bacterial endocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0014121
uncontrolled hypertension: systolic blood pressure > 180 mm hg and/or diastolic blood pressure > 110 mm hg
Description

uncontrolled hypertension

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Description

lactating

Data type

boolean

Alias
UMLS CUI [1]
C2828358
any other contraindication listed in the labeling of warfarin or acenocoumarol
Description

contraindication Warfarin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
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Similar models

Eligibility Atrial Fibrillation NCT00070655

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
atrial fibrillation: vitamin k antagonist therapy
Item
ecg-documented atrial fibrillation (af) and an indication for long-term vitamin k antagonist (vka) therapy based on the presence of at least one of the following risk factors:
boolean
C0004238 (UMLS CUI [1])
C1096489 (UMLS CUI [2])
ischemic stroke; systemic embolism
Item
1. previous ischemic stroke, transient ischemic attack (tia) or systemic embolism
boolean
C0948008 (UMLS CUI [1])
C0149876 (UMLS CUI [2])
hypertension treatment required
Item
2. hypertension requiring drug treatment
boolean
C0020538 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
left ventricular ejection fraction; symptomatic congestive heart failure
Item
3. left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
boolean
C0428772 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
Age
Item
4. age >75 years
boolean
C0001779 (UMLS CUI [1])
age; Diabetes Mellitus
Item
5. age between 65-75 years plus diabetes mellitus, or
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
age; symptomatic coronary artery disease
Item
6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (mi) or angina pectoris)
boolean
C0001779 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age Limitation
Item
legal lower age limitations (country specific)
boolean
C0001779 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
vitamin k antagonist therapy; Heart Valve Prosthesis
Item
indication for vka other than af, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
boolean
C1096489 (UMLS CUI [1])
C0018825 (UMLS CUI [2])
atrial fibrillation
Item
transient af caused by a reversible disorder
boolean
C0004238 (UMLS CUI [1])
active bleeding
Item
active bleeding or high risk of bleeding
boolean
C0019080 (UMLS CUI [1])
major surgery
Item
recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
boolean
C0679637 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in another pharmacotherapeutic study within the prior 30 days
boolean
C2348568 (UMLS CUI [1])
creatinine clearance; hepatic disease; bacterial endocarditis
Item
creatinine clearance <10 ml/min, severe hepatic disease, or bacterial endocarditis
boolean
C0373595 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0014121 (UMLS CUI [3])
uncontrolled hypertension
Item
uncontrolled hypertension: systolic blood pressure > 180 mm hg and/or diastolic blood pressure > 110 mm hg
boolean
C1868885 (UMLS CUI [1])
Pregnancy
Item
pregnancy or childbearing potential without proper contraceptive measures
boolean
C0032961 (UMLS CUI [1])
lactating
Item
breastfeeding
boolean
C2828358 (UMLS CUI [1])
contraindication Warfarin
Item
any other contraindication listed in the labeling of warfarin or acenocoumarol
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
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