ID

31996

Beschrijving

EUropean Pharmacogenetics of AntiCoagulant Therapy - Phenprocoumon; ODM derived from: https://clinicaltrials.gov/show/NCT01119274 Sponsor: Utrecht Institute for Pharmaceutical Sciences Collaborators: Utrecht University Leiden University Medical Center Erasmus Medical Center University of Ulm Newcastle University University of Liverpool LGC Limited Uppsala University Democritus University of Thrace Elisabethinen Hospital Information provided by (Responsible Party): Anke-Hilse Maitland-van der Zee, Utrecht Institute for Pharmaceutical Sciences

Link

https://clinicaltrials.gov/show/NCT01119274

Trefwoorden

Versies (1)
  1. 10-10-18 10-10-18 -
Houder van rechten

Anke-Hilse Maitland-van der Zee, PharmD, PhD, Utrecht Institute for Pharmaceutical Sciences

Geüploaded op

10 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Venous Thromboembolism (VTE) Phenprocoumon NCT01119274

Engels

Eligibility Venous Thromboembolism (VTE) Phenprocoumon NCT01119274

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with either venous thromboembolism (vte) or atrial fibrillation (af) requiring coumarin therapy for at least 12 weeks and a target inr in the low intensity range (inr range 2-3 in the united kingdom, sweden, germany, austria and greece and inr 2.5-3.5 in the netherlands)
Beschrijving

Venous thromboembolism, atrial fibrillation requiring coumarin therapy, target inr in the low intensity range

Datatype

boolean

Alias
UMLS CUI [1,1]
C1861172
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0010206
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0010206
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0525032
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ability to attend scheduled visits
Beschrijving

Ability to attend scheduled visits

Datatype

boolean

Alias
UMLS CUI [1,1]
C2827364
UMLS CUI [1,2]
C0085732
signed informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of a mechanical heart valve
Beschrijving

Presence of a mechanical heart valve

Datatype

boolean

Alias
UMLS CUI [1]
C0493527
severe cognitive impairment
Beschrijving

Severe cognitive impairment

Datatype

boolean

Alias
UMLS CUI [1]
C3554639
known genotype cyp2c9 or vkorc1 at start of the study
Beschrijving

Known genotype cyp2c9 or vkorc1

Datatype

boolean

Alias
UMLS CUI [1]
C1332829
UMLS CUI [2]
C1428184
previous or current treatment with any coumarin
Beschrijving

Previous or current treatment with any coumarin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010206
UMLS CUI [1,2]
C2827774
UMLS CUI [2,1]
C0010206
UMLS CUI [2,2]
C1514463
pregnancy or lactation
Beschrijving

Pregnancy or lactation

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
non-eligible subject
Beschrijving

Ineligibility

Datatype

boolean

Alias
UMLS CUI [1]
C1512714
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Similar models

Eligibility Venous Thromboembolism (VTE) Phenprocoumon NCT01119274

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Venous thromboembolism, atrial fibrillation requiring coumarin therapy, target inr in the low intensity range
Item
patients with either venous thromboembolism (vte) or atrial fibrillation (af) requiring coumarin therapy for at least 12 weeks and a target inr in the low intensity range (inr range 2-3 in the united kingdom, sweden, germany, austria and greece and inr 2.5-3.5 in the netherlands)
boolean
C1861172 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0010206 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0010206 (UMLS CUI [2,3])
C1521840 (UMLS CUI [3,1])
C0525032 (UMLS CUI [3,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Ability to attend scheduled visits
Item
ability to attend scheduled visits
boolean
C2827364 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Presence of a mechanical heart valve
Item
presence of a mechanical heart valve
boolean
C0493527 (UMLS CUI [1])
Severe cognitive impairment
Item
severe cognitive impairment
boolean
C3554639 (UMLS CUI [1])
Known genotype cyp2c9 or vkorc1
Item
known genotype cyp2c9 or vkorc1 at start of the study
boolean
C1332829 (UMLS CUI [1])
C1428184 (UMLS CUI [2])
Previous or current treatment with any coumarin
Item
previous or current treatment with any coumarin
boolean
C0010206 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0010206 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
Pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
Ineligibility
Item
non-eligible subject
boolean
C1512714 (UMLS CUI [1])
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