ID

12876

Description

RIvaroxaban for Valvular Heart disease and atRial Fibrillation Trial -RIVER Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02303795

Link

https://clinicaltrials.gov/show/NCT02303795

Keywords

Versions (1)
  1. 1/4/16 1/4/16 -
Uploaded on

January 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Valvular Heart Disease NCT02303795

English

Eligibility Valvular Heart Disease NCT02303795

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients aged >18 and < 80 years at time of inclusion
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
Description

Paroxysmal atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
the patient must be able to give informed consent
Description

informed consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
Description

cardiovascular disease; tumor

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027651
active endocarditis
Description

endocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0014118
uncontrolled hypertension
Description

uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
2. hemorrhage risk-related criteria
Description

hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
active internal bleeding
Description

internal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C1390214
history of, or condition associated with, increased bleeding risk
Description

Medical History hemorrhage

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019080
3. concomitant conditions and therapies
Description

concomitant conditions

Data type

boolean

Alias
UMLS CUI [1]
C0243086
history of previous thromboembolism with high risk of bleeding:
Description

thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C0040038
severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
Description

stroke

Data type

boolean

Alias
UMLS CUI [1]
C0038454
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
Description

thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0040053
acute mi within the last 14 days prior to randomization
Description

Acute myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0155626
treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
Description

aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C1096021
UMLS CUI [3]
C0003211
anemia
Description

anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
calculated creatinine clearance b30 ml/min
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
known significant liver disease or alanine aminotransferase n3× the upper limit of normal
Description

liver disease; alanine aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0001899
previous participation in this study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Valvular Heart Disease NCT02303795

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. male and female patients aged >18 and < 80 years at time of inclusion
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation
Item
2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
boolean
C0235480 (UMLS CUI [1])
informed consent
Item
the patient must be able to give informed consent
boolean
Item Group
C0680251 (UMLS CUI)
cardiovascular disease; tumor
Item
1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
boolean
C0007222 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
endocarditis
Item
active endocarditis
boolean
C0014118 (UMLS CUI [1])
uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
hemorrhage
Item
2. hemorrhage risk-related criteria
boolean
C0019080 (UMLS CUI [1])
internal bleeding
Item
active internal bleeding
boolean
C1390214 (UMLS CUI [1])
Medical History hemorrhage
Item
history of, or condition associated with, increased bleeding risk
boolean
C0262926 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
concomitant conditions
Item
3. concomitant conditions and therapies
boolean
C0243086 (UMLS CUI [1])
thromboembolism
Item
history of previous thromboembolism with high risk of bleeding:
boolean
C0040038 (UMLS CUI [1])
stroke
Item
severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
boolean
C0038454 (UMLS CUI [1])
thrombosis
Item
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
boolean
C0040053 (UMLS CUI [1])
Acute myocardial infarction
Item
acute mi within the last 14 days prior to randomization
boolean
C0155626 (UMLS CUI [1])
aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug
Item
treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
boolean
C0004057 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
pregnancy; lactating
Item
pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
creatinine clearance
Item
calculated creatinine clearance b30 ml/min
boolean
C0373595 (UMLS CUI [1])
liver disease; alanine aminotransferase
Item
known significant liver disease or alanine aminotransferase n3× the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
Study Subject Participation Status
Item
previous participation in this study.
boolean
C2348568 (UMLS CUI [1])
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