ID

43670

Description

Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention; ODM derived from: https://clinicaltrials.gov/show/NCT02273700

Link

https://clinicaltrials.gov/show/NCT02273700

Keywords

Versions (2)
  1. 4/25/16 4/25/16 -
  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 NCT02273700

English

Eligibility Atrial Fibrillation NCT02273700

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient was correctly informed about the study, its implementation, objectives, associated restrictions and patient rights
Description

Informing patient Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0588446
UMLS CUI [1,2]
C2603343
the patient must have given his/her informed and signed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the patient must be insured or beneficiary of a health insurance plan
Description

health insurance plan

Data type

boolean

Alias
UMLS CUI [1]
C0679933
the patient is available for 1 month of follow-up
Description

Availability Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1522577
the patient has non-valvular atrial fibrillation that was diagnosed within the last 3 months. documentation of atrial fibrillation by a 12-lead ecg, an ecg rhythm strip, atrial fibrillation episode lasting at least 30 seconds.
Description

Atrial Fibrillation | 12 lead ECG | electrocardiogram rhythm strip | Episode of Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0430456
UMLS CUI [3]
C2022160
UMLS CUI [4,1]
C0332189
UMLS CUI [4,2]
C0004238
the patient has a cha2-ds2-vasc score = 1, that is to say the presence of at least one of the following risk factors: (1) congestive heart failure or moderate to severe systolic dysfunction of the left ventricle; (2) history of systolic blood pressure> 160 mmhg; (3) diabetes; (4) history of ischemic stroke or systemic embolism; (5) vascular disease (myocardial infarction, arterial disease); (6) age > 65 years; (7) female.
Description

Cerebrovascular accident Score | Congestive heart failure | Moderate left ventricular systolic dysfunction | Severe left ventricular systolic dysfunction | Systolic Pressure | Diabetes Mellitus | Ischemic stroke | EMBOLISM, SYSTEMIC ARTERIAL | Vascular Diseases | Myocardial Infarction | Arteriopathic disease | Age | Female

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0449820
UMLS CUI [2]
C0018802
UMLS CUI [3]
C3266752
UMLS CUI [4]
C3266753
UMLS CUI [5]
C0871470
UMLS CUI [6]
C0011849
UMLS CUI [7]
C0948008
UMLS CUI [8]
C0149876
UMLS CUI [9]
C0042373
UMLS CUI [10]
C0027051
UMLS CUI [11]
C0852949
UMLS CUI [12]
C0001779
UMLS CUI [13]
C0086287
the patient will start rivaroxaban (xarelto®) at the nîmes university hospital
Description

rivaroxaban Xarelto | Hospitals, University

Data type

boolean

Alias
UMLS CUI [1,1]
C1739768
UMLS CUI [1,2]
C3159309
UMLS CUI [2]
C0020028
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient is participating in another interventional study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
the patient has participated in another interventional study within the past three months
Description

Study Subject Participation Status Past

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1444637
the patient is in an exclusion period determined by a previous study
Description

Exclusion Criteria Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1948053
the patient is under judicial protection, under tutorship or curatorship
Description

judicial aspects

Data type

boolean

Alias
UMLS CUI [1]
C0243116
the patient refuses to sign the consent
Description

Unwilling Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0021430
it is impossible to correctly inform the patient
Description

Informing patient Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0588446
UMLS CUI [1,2]
C1272705
the patient is pregnant, parturient, or breastfeeding
Description

Pregnancy | Parturition | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0005615
UMLS CUI [3]
C0006147
presence of a mechanical heart valve or valve disease
Description

HEART-VALVE, MECHANICAL | Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0493527
UMLS CUI [2]
C0018824
patient who recieved another new direct oral anticoagulant other than xarelto® in the previous three months
Description

Other oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Atrial Fibrillation NCT02273700

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informing patient Study
Item
the patient was correctly informed about the study, its implementation, objectives, associated restrictions and patient rights
boolean
C0588446 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Informed Consent
Item
the patient must have given his/her informed and signed consent
boolean
C0021430 (UMLS CUI [1])
health insurance plan
Item
the patient must be insured or beneficiary of a health insurance plan
boolean
C0679933 (UMLS CUI [1])
Availability Follow-up
Item
the patient is available for 1 month of follow-up
boolean
C0470187 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Atrial Fibrillation | 12 lead ECG | electrocardiogram rhythm strip | Episode of Atrial Fibrillation
Item
the patient has non-valvular atrial fibrillation that was diagnosed within the last 3 months. documentation of atrial fibrillation by a 12-lead ecg, an ecg rhythm strip, atrial fibrillation episode lasting at least 30 seconds.
boolean
C0004238 (UMLS CUI [1])
C0430456 (UMLS CUI [2])
C2022160 (UMLS CUI [3])
C0332189 (UMLS CUI [4,1])
C0004238 (UMLS CUI [4,2])
Cerebrovascular accident Score | Congestive heart failure | Moderate left ventricular systolic dysfunction | Severe left ventricular systolic dysfunction | Systolic Pressure | Diabetes Mellitus | Ischemic stroke | EMBOLISM, SYSTEMIC ARTERIAL | Vascular Diseases | Myocardial Infarction | Arteriopathic disease | Age | Female
Item
the patient has a cha2-ds2-vasc score = 1, that is to say the presence of at least one of the following risk factors: (1) congestive heart failure or moderate to severe systolic dysfunction of the left ventricle; (2) history of systolic blood pressure> 160 mmhg; (3) diabetes; (4) history of ischemic stroke or systemic embolism; (5) vascular disease (myocardial infarction, arterial disease); (6) age > 65 years; (7) female.
boolean
C0038454 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C3266752 (UMLS CUI [3])
C3266753 (UMLS CUI [4])
C0871470 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
C0948008 (UMLS CUI [7])
C0149876 (UMLS CUI [8])
C0042373 (UMLS CUI [9])
C0027051 (UMLS CUI [10])
C0852949 (UMLS CUI [11])
C0001779 (UMLS CUI [12])
C0086287 (UMLS CUI [13])
rivaroxaban Xarelto | Hospitals, University
Item
the patient will start rivaroxaban (xarelto®) at the nîmes university hospital
boolean
C1739768 (UMLS CUI [1,1])
C3159309 (UMLS CUI [1,2])
C0020028 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
the patient is participating in another interventional study
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Past
Item
the patient has participated in another interventional study within the past three months
boolean
C2348568 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Exclusion Criteria Period
Item
the patient is in an exclusion period determined by a previous study
boolean
C0680251 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
judicial aspects
Item
the patient is under judicial protection, under tutorship or curatorship
boolean
C0243116 (UMLS CUI [1])
Unwilling Informed Consent
Item
the patient refuses to sign the consent
boolean
C0558080 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Informing patient Unsuccessful
Item
it is impossible to correctly inform the patient
boolean
C0588446 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Pregnancy | Parturition | Breast Feeding
Item
the patient is pregnant, parturient, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0005615 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
HEART-VALVE, MECHANICAL | Heart valve disease
Item
presence of a mechanical heart valve or valve disease
boolean
C0493527 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
Other oral anticoagulants
Item
patient who recieved another new direct oral anticoagulant other than xarelto® in the previous three months
boolean
C0354604 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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