ID

4437

Beschrijving

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study).

Trefwoorden

Versies (1)
  1. 09-12-13 09-12-13 - Martin Dugas
Geüploaded op

9 december 2013

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00439725 Deep Vein Thrombosis

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschrijving

Inclusion criteria

18 Years and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Beschrijving

Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban

Datatype

boolean

Alias
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
UMLS CUI
C1096489
MDR
10053755
UMLS CUI
C1739768
SNOMED CT 2010_0731
442031002
Exclusion criteria
Beschrijving

Exclusion criteria

Legal lower age limitations (country specific)
Beschrijving

Legal lower age limitations (country specific)

Datatype

boolean

Alias
UMLS CUI
C0680135
UMLS CUI
C0682055
Indication for VKA other than DVT and/or PE
Beschrijving

Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis

Datatype

boolean

Alias
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
UMLS CUI
C1096489
MDR
10053755
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
Beschrijving

Anticoagulation treatment should be continued

Datatype

boolean

Alias
UMLS CUI
C0150457
MDR
10053468
SNOMED CT 2010_0731
182764009
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Beschrijving

No contraception, No pregnancy or breast feeding

Datatype

boolean

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
UMLS CUI
C0549206
MDR
10036586
SNOMED CT 2010_0731
77386006
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
Medical Concepts
Beschrijving

Medical Concepts

Age
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Pulmonary Embolism
Beschrijving

Pulmonary Embolism

Datatype

string

Alias
UMLS CUI
C0034065
ICD10CM
I26.99
MDR
10037377
SNOMED CT 2010_0731
59282003
Deep Vein Thrombosis
Beschrijving

Deep Vein Thrombosis

Datatype

string

Alias
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
Vitamin K antagonist
Beschrijving

Vitamin K antagonist

Datatype

string

Alias
UMLS CUI
C1096489
MDR
10053755
Rivaroxaban
Beschrijving

Rivaroxaban

Datatype

string

Alias
UMLS CUI
C1739768
SNOMED CT 2010_0731
442031002
age restriction in context
Beschrijving

age restriction in context

Datatype

string

Alias
UMLS CUI
C0680135
age subdivision of legal significance
Beschrijving

age subdivision of legal significance

Datatype

string

Alias
UMLS CUI
C0682055
Anticoagulant therapy
Beschrijving

Anticoagulant therapy

Datatype

string

Alias
UMLS CUI
C0150457
MDR
10053468
SNOMED CT 2010_0731
182764009
Contraceptive methods
Beschrijving

Contraceptive methods

Datatype

string

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Patient currently pregnant
Beschrijving

Patient currently pregnant

Datatype

string

Alias
UMLS CUI
C0549206
MDR
10036586
SNOMED CT 2010_0731
77386006
Breast Feeding
Beschrijving

Breast Feeding

Datatype

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion criteria
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban
Item
Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
boolean
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
C1096489 (UMLS CUI)
10053755 (MDR)
C1739768 (UMLS CUI)
442031002 (SNOMED CT 2010_0731)
Item Group
Exclusion criteria
Legal lower age limitations (country specific)
Item
Legal lower age limitations (country specific)
boolean
C0680135 (UMLS CUI)
C0682055 (UMLS CUI)
Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
Item
Indication for VKA other than DVT and/or PE
boolean
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
C1096489 (UMLS CUI)
10053755 (MDR)
Anticoagulation treatment should be continued
Item
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
boolean
C0150457 (UMLS CUI)
10053468 (MDR)
182764009 (SNOMED CT 2010_0731)
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
No contraception, No pregnancy or breast feeding
Item
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
boolean
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Pulmonary Embolism
Item
Pulmonary Embolism
string
C0034065 (UMLS CUI)
I26.99 (ICD10CM)
10037377 (MDR)
59282003 (SNOMED CT 2010_0731)
Deep Vein Thrombosis
Item
Deep Vein Thrombosis
string
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
Vitamin K antagonist
Item
Vitamin K antagonist
string
C1096489 (UMLS CUI)
10053755 (MDR)
Rivaroxaban
Item
Rivaroxaban
string
C1739768 (UMLS CUI)
442031002 (SNOMED CT 2010_0731)
age restriction in context
Item
age restriction in context
string
C0680135 (UMLS CUI)
age subdivision of legal significance
Item
age subdivision of legal significance
string
C0682055 (UMLS CUI)
Anticoagulant therapy
Item
Anticoagulant therapy
string
C0150457 (UMLS CUI)
10053468 (MDR)
182764009 (SNOMED CT 2010_0731)
Contraceptive methods
Item
Contraceptive methods
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Patient currently pregnant
Item
Patient currently pregnant
string
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMED CT 2010_0731)
Breast Feeding
Item
Breast Feeding
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
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