ID

19524

Description

A Pharmacogenetic Study of Warfarin Dosing, "The COUMA-GEN Study"; ODM derived from: https://clinicaltrials.gov/show/NCT00334464

Lien

https://clinicaltrials.gov/show/NCT00334464

Mots-clés

Versions (1)
  1. 06/01/2017 06/01/2017 -
Téléchargé le

6 janvier 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00334464

Anglais

Eligibility Atrial Fibrillation NCT00334464

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient (male or non-pregnant/non lactating female1) must be > 18 years of age.
Description

Age | Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
the patient or legally authorized representative must sign a written informed consent, prior to the procedure.
Description

Informed Consent | Informed Consent Patient Representative

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
the potentially eligible patient is at high (post-orthopedic surgery) risk of dvt and the treatment plan will include anticoagulation using warfarin with standard of care follow up including inr assessment.
Description

Deep Vein Thrombosis High risk of | Orthopedic Surgical Procedure Status post | Anticoagulation Therapy | Warfarin | Standard Follow-Up Care | INR test

Type de données

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C1136201
UMLS CUI [2,2]
C0231290
UMLS CUI [3]
C0003281
UMLS CUI [4]
C0043031
UMLS CUI [5]
C3897505
UMLS CUI [6]
C0851084
the potentially eligible patient is diagnosed with dvt or at high (post-orthopedic surgery) risk of dvt and the treatment plan will include anticoagulation using warfarin with standard of care follow up including inr assessment.
Description

Deep Vein Thrombosis | Deep Vein Thrombosis High risk of | Orthopedic Surgical Procedure Status post | Anticoagulation Therapy | Warfarin | Standard Follow-Up Care | INR test

Type de données

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2,1]
C0149871
UMLS CUI [2,2]
C0332167
UMLS CUI [3,1]
C1136201
UMLS CUI [3,2]
C0231290
UMLS CUI [4]
C0003281
UMLS CUI [5]
C0043031
UMLS CUI [6]
C3897505
UMLS CUI [7]
C0851084
patient is diagnosed with atrial fibrillation (af) and the treatment plan will include anticoagulation using warfarin with standard of care follow up including inr assessment.
Description

Atrial Fibrillation | Anticoagulation Therapy | Warfarin | Standard Follow-Up Care | INR test

Type de données

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0003281
UMLS CUI [3]
C0043031
UMLS CUI [4]
C3897505
UMLS CUI [5]
C0851084
heart failure patients (ef<25% or apical akinesis or left ventricular aneurysm or extensive wall motion abnormality) in sinus rhythm being started on warfarin to reduce the risk of thromboembolism.
Description

Heart failure Sinus rhythm | Cardiac ejection fraction | Akinesia Apical | Left ventricular aneurysm | Cardiac wall motion Abnormality Extensive | Warfarin | Thromboembolism Risk Reducing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0232201
UMLS CUI [2]
C0232174
UMLS CUI [3,1]
C0085623
UMLS CUI [3,2]
C0205111
UMLS CUI [4]
C0519097
UMLS CUI [5,1]
C0232167
UMLS CUI [5,2]
C1704258
UMLS CUI [5,3]
C0205231
UMLS CUI [6]
C0043031
UMLS CUI [7,1]
C0040038
UMLS CUI [7,2]
C0035647
UMLS CUI [7,3]
C0392756
women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period.
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
women of childbearing potential must have a negative pregnancy test at screen.
Description

Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant and/or lactating women and women of child bearing potential not using acceptable means of contraception.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unacceptable

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1883420
participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Description

Study Subject Participation Status | Investigational New Drugs | marketed products

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0683746
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Similar models

Eligibility Atrial Fibrillation NCT00334464

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy | Breast Feeding
Item
the patient (male or non-pregnant/non lactating female1) must be > 18 years of age.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Informed Consent | Informed Consent Patient Representative
Item
the patient or legally authorized representative must sign a written informed consent, prior to the procedure.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Deep Vein Thrombosis High risk of | Orthopedic Surgical Procedure Status post | Anticoagulation Therapy | Warfarin | Standard Follow-Up Care | INR test
Item
the potentially eligible patient is at high (post-orthopedic surgery) risk of dvt and the treatment plan will include anticoagulation using warfarin with standard of care follow up including inr assessment.
boolean
C0149871 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1136201 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C0003281 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
C3897505 (UMLS CUI [5])
C0851084 (UMLS CUI [6])
Deep Vein Thrombosis | Deep Vein Thrombosis High risk of | Orthopedic Surgical Procedure Status post | Anticoagulation Therapy | Warfarin | Standard Follow-Up Care | INR test
Item
the potentially eligible patient is diagnosed with dvt or at high (post-orthopedic surgery) risk of dvt and the treatment plan will include anticoagulation using warfarin with standard of care follow up including inr assessment.
boolean
C0149871 (UMLS CUI [1])
C0149871 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C1136201 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
C0003281 (UMLS CUI [4])
C0043031 (UMLS CUI [5])
C3897505 (UMLS CUI [6])
C0851084 (UMLS CUI [7])
Atrial Fibrillation | Anticoagulation Therapy | Warfarin | Standard Follow-Up Care | INR test
Item
patient is diagnosed with atrial fibrillation (af) and the treatment plan will include anticoagulation using warfarin with standard of care follow up including inr assessment.
boolean
C0004238 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C3897505 (UMLS CUI [4])
C0851084 (UMLS CUI [5])
Heart failure Sinus rhythm | Cardiac ejection fraction | Akinesia Apical | Left ventricular aneurysm | Cardiac wall motion Abnormality Extensive | Warfarin | Thromboembolism Risk Reducing
Item
heart failure patients (ef<25% or apical akinesis or left ventricular aneurysm or extensive wall motion abnormality) in sinus rhythm being started on warfarin to reduce the risk of thromboembolism.
boolean
C0018801 (UMLS CUI [1,1])
C0232201 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
C0085623 (UMLS CUI [3,1])
C0205111 (UMLS CUI [3,2])
C0519097 (UMLS CUI [4])
C0232167 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C0205231 (UMLS CUI [5,3])
C0043031 (UMLS CUI [6])
C0040038 (UMLS CUI [7,1])
C0035647 (UMLS CUI [7,2])
C0392756 (UMLS CUI [7,3])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative
Item
women of childbearing potential must have a negative pregnancy test at screen.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unacceptable
Item
pregnant and/or lactating women and women of child bearing potential not using acceptable means of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1883420 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | marketed products
Item
participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0683746 (UMLS CUI [3])
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