ID

43932

Description

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I); ODM derived from: https://clinicaltrials.gov/show/NCT00249795

Link

https://clinicaltrials.gov/show/NCT00249795

Keywords

Versions (2)
  1. 7/3/16 7/3/16 -
  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 NCT00249795

English

Eligibility Atrial Fibrillation NCT00249795

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
should fulfill the eligibility criteria for active a or active w trial and:
Description

Clinical Trial Eligibility Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
have a systolic blood pressure of at least 110 mmhg
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
Description

Angiotensin II receptor antagonist | Antihypertensive Agent Change Willing

Data type

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0600109
no previous intolerance to angiotensin receptor blocking agents
Description

intolerance to Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0521942
no proven indication for angiotensin receptor blocking agents, unless an angiotensin converting enzyme (ace) inhibitor can be substituted
Description

Indication Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors Substitution

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0521942
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C1706204
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from active study if any of the following are present:
Description

ID.6

Data type

boolean

requirement for clopidogrel (such as recent coronary stent procedure)
Description

clopidogrel Requirement | Coronary stent placement

Data type

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C1514873
UMLS CUI [2]
C0948884
requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
Description

oral anticoagulants Requirement | Artificial cardiac valve prosthesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C1514873
UMLS CUI [2]
C3873910
prior intolerance to acetylsalicyclic acid (asa) or clopidogrel
Description

intolerance to Aspirin | intolerance to clopidogrel

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0070166
documented peptic ulcer disease within the previous 6 months
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
prior intracerebral hemorrhage
Description

Cerebral Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C2937358
significant thrombocytopenia (platelet count <50 x 10(9)/l)
Description

Thrombocytopenia Significant | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0032181
psychosocial reason making study participation impractical
Description

Psychosocial Factors Causing Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0033963
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
geographic reason making study participation impractical
Description

Geographic Factors Causing Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0017444
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
ongoing alcohol abuse
Description

Alcohol abuse Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0549178
mitral stenosis
Description

Mitral Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0026269
pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Not used | Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0445107
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
severe comorbid condition such that the patient is not expected to survive 6 months
Description

Comorbidity Severe | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023671
patient currently receiving an investigational pharmacologic agent
Description

Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-cox-2) inhibitor nonsteroidal anti-inflammatory drug (nsaid) therapy unless willing enrolled in active a
Description

Cyclooxygenase 2 Inhibitors chronic Therapeutic procedure Requirement | Anti-Inflammatory Agents, Non-Steroidal chronic Therapeutic procedure Requirement

Data type

boolean

Alias
UMLS CUI [1,1]
C1257954
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1514873
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1514873
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Similar models

Eligibility Atrial Fibrillation NCT00249795

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Eligibility Criteria Fulfill
Item
should fulfill the eligibility criteria for active a or active w trial and:
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Systolic Pressure
Item
have a systolic blood pressure of at least 110 mmhg
boolean
C0871470 (UMLS CUI [1])
Angiotensin II receptor antagonist | Antihypertensive Agent Change Willing
Item
not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
boolean
C0521942 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
intolerance to Angiotensin II receptor antagonist
Item
no previous intolerance to angiotensin receptor blocking agents
boolean
C1744706 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
Indication Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors Substitution
Item
no proven indication for angiotensin receptor blocking agents, unless an angiotensin converting enzyme (ace) inhibitor can be substituted
boolean
C3146298 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2,1])
C1706204 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
patients will be excluded from active study if any of the following are present:
boolean
clopidogrel Requirement | Coronary stent placement
Item
requirement for clopidogrel (such as recent coronary stent procedure)
boolean
C0070166 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0948884 (UMLS CUI [2])
oral anticoagulants Requirement | Artificial cardiac valve prosthesis
Item
requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
boolean
C0354604 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3873910 (UMLS CUI [2])
intolerance to Aspirin | intolerance to clopidogrel
Item
prior intolerance to acetylsalicyclic acid (asa) or clopidogrel
boolean
C1744706 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
Peptic Ulcer
Item
documented peptic ulcer disease within the previous 6 months
boolean
C0030920 (UMLS CUI [1])
Cerebral Hemorrhage
Item
prior intracerebral hemorrhage
boolean
C2937358 (UMLS CUI [1])
Thrombocytopenia Significant | Platelet Count measurement
Item
significant thrombocytopenia (platelet count <50 x 10(9)/l)
boolean
C0040034 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
Psychosocial Factors Causing Study Subject Participation Status Limited
Item
psychosocial reason making study participation impractical
boolean
C0033963 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Geographic Factors Causing Study Subject Participation Status Limited
Item
geographic reason making study participation impractical
boolean
C0017444 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Alcohol abuse Continuous
Item
ongoing alcohol abuse
boolean
C0085762 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Mitral Stenosis
Item
mitral stenosis
boolean
C0026269 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Not used | Contraceptive methods Unwilling
Item
pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0445107 (UMLS CUI [3,3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Comorbidity Severe | Life Expectancy
Item
severe comorbid condition such that the patient is not expected to survive 6 months
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
Investigational New Drug
Item
patient currently receiving an investigational pharmacologic agent
boolean
C0013230 (UMLS CUI [1])
Cyclooxygenase 2 Inhibitors chronic Therapeutic procedure Requirement | Anti-Inflammatory Agents, Non-Steroidal chronic Therapeutic procedure Requirement
Item
requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-cox-2) inhibitor nonsteroidal anti-inflammatory drug (nsaid) therapy unless willing enrolled in active a
boolean
C1257954 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1514873 (UMLS CUI [2,4])
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