ID

25780

Description

Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00448214

Link

https://clinicaltrials.gov/show/NCT00448214

Keywords

  1. 9/19/17 9/19/17 -
Uploaded on

September 19, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT00448214

Eligibility Atrial Fibrillation NCT00448214

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects are eligible for the study if all of the following apply:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject has paroxysmal permanent or persistent nvaf
Description

Paroxysmal atrial fibrillation | Permanent atrial fibrillation | Persistent atrial fibrillation | Heart valve disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2586056
UMLS CUI [3]
C2585653
UMLS CUI [4,1]
C0018824
UMLS CUI [4,2]
C0332197
subject has inr of 2.0 or below and an aptt ≤ 1.5 times the upper limit of normal at the baseline visit.
Description

International Normalized Ratio | Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0030605
legal minimum age requirement (country-specific).
Description

Age Legal Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1301860
UMLS CUI [1,3]
C1524031
written informed consent has been obtained.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of heart valve disorders
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
history of rheumatic fever.
Description

Rheumatic Fever

Data type

boolean

Alias
UMLS CUI [1]
C0035436
history of stroke and/or systemic embolism (including tia).
Description

Cerebrovascular accident | EMBOLISM, SYSTEMIC ARTERIAL | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0149876
UMLS CUI [3]
C0007787
history of acute coronary syndrome (acs).
Description

Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
indication for warfarin other than nvaf.
Description

Indication Warfarin | Exception Atrial Fibrillation Without Heart valve disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0043031
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0018824
known hemorrhagic disorder and/or coagulation disorder.
Description

Hemorrhagic Disorders | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0019087
UMLS CUI [2]
C0005779
active bleeding or any condition associated with increased risk of bleeding.
Description

Hemorrhage | Condition Associated with Bleeding Risk

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C3251812

Similar models

Eligibility Atrial Fibrillation NCT00448214

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects are eligible for the study if all of the following apply:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Paroxysmal atrial fibrillation | Permanent atrial fibrillation | Persistent atrial fibrillation | Heart valve disease Absent
Item
subject has paroxysmal permanent or persistent nvaf
boolean
C0235480 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
C2585653 (UMLS CUI [3])
C0018824 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
International Normalized Ratio | Activated Partial Thromboplastin Time measurement
Item
subject has inr of 2.0 or below and an aptt ≤ 1.5 times the upper limit of normal at the baseline visit.
boolean
C0525032 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Age Legal Minimum
Item
legal minimum age requirement (country-specific).
boolean
C0001779 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart valve disease
Item
history of heart valve disorders
boolean
C0018824 (UMLS CUI [1])
Rheumatic Fever
Item
history of rheumatic fever.
boolean
C0035436 (UMLS CUI [1])
Cerebrovascular accident | EMBOLISM, SYSTEMIC ARTERIAL | Transient Ischemic Attack
Item
history of stroke and/or systemic embolism (including tia).
boolean
C0038454 (UMLS CUI [1])
C0149876 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Acute Coronary Syndrome
Item
history of acute coronary syndrome (acs).
boolean
C0948089 (UMLS CUI [1])
Indication Warfarin | Exception Atrial Fibrillation Without Heart valve disease
Item
indication for warfarin other than nvaf.
boolean
C3146298 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0018824 (UMLS CUI [2,4])
Hemorrhagic Disorders | Blood Coagulation Disorders
Item
known hemorrhagic disorder and/or coagulation disorder.
boolean
C0019087 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Hemorrhage | Condition Associated with Bleeding Risk
Item
active bleeding or any condition associated with increased risk of bleeding.
boolean
C0019080 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])

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