ID

34806

Descripción

Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF); ODM derived from: https://clinicaltrials.gov/show/NCT02240667

Link

https://clinicaltrials.gov/show/NCT02240667

Palabras clave

Versiones (1)
  1. 30/1/19 30/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

30 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02240667

Inglés

Eligibility Atrial Fibrillation NCT02240667

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly prescribed treatment with pradaxa® (dabigatranetexilat)/vitamine k antagonist (vka) in indication stroke prevention in non-valvular atrial fibrillation (af), respecting indication and contraindications as described in the respective summary of product characteristics for pradaxa®110 mg resp. 150 mg capsules, resp. vka.
Descripción

Pradaxa prescribed | dabigatran etexilate | Vitamin K antagonists | Stroke prevention | Atrial Fibrillation | Heart Valve Involvement Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2940579
UMLS CUI [1,2]
C0278329
UMLS CUI [2]
C1571583
UMLS CUI [3]
C3653316
UMLS CUI [4]
C1277289
UMLS CUI [5]
C0004238
UMLS CUI [6,1]
C0018826
UMLS CUI [6,2]
C1314939
UMLS CUI [6,3]
C0332197
patients suitable for therapy with pradaxa as well as with vka.
Descripción

Patients Appropriate Pradaxa | Patients Appropriate Vitamin K antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2940579
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C3653316
treatment with dabigatranetexilat resp. vka follows summary of product characteristics.
Descripción

dabigatran etexilate | Vitamin K antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1571583
UMLS CUI [2]
C3653316
the usual routine in diagnostics and treatment will not be modified.
Descripción

Routine Diagnostic unchanged | Routine Treatment unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205547
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0442739
UMLS CUI [2,1]
C0205547
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0442739
only patients will be documented qualifying for vka-therapy as well as for dabigatranetexilat acc. to pradaxa® resp. vka summary of product characteristics.
Descripción

Qualification Vitamin K antagonists | Qualification Dabigatran etexilate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1709790
UMLS CUI [1,2]
C3653316
UMLS CUI [2,1]
C1709790
UMLS CUI [2,2]
C1571583
written informed consent before inclusion.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with general or special contraindications acc. to summary of product characteristics.
Descripción

Medical contraindication General | Medical contraindication Special

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205246
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0205555
patients participating at the same time or within the last 30 days in another non-interventional study (nis) or interventional clinical trial.
Descripción

Study Subject Participation Status | Clinical Trial Without Interventional procedure | Interventional Study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0184661
UMLS CUI [3]
C3274035
patients needing anticoagulative treatment for indications other than non-valvular atrial fibrillation.
Descripción

Patient need for Anticoagulation Therapy | Exception Indication Atrial Fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0004238
pregnancy or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Atrial Fibrillation NCT02240667

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Pradaxa prescribed | dabigatran etexilate | Vitamin K antagonists | Stroke prevention | Atrial Fibrillation | Heart Valve Involvement Absent
Item
newly prescribed treatment with pradaxa® (dabigatranetexilat)/vitamine k antagonist (vka) in indication stroke prevention in non-valvular atrial fibrillation (af), respecting indication and contraindications as described in the respective summary of product characteristics for pradaxa®110 mg resp. 150 mg capsules, resp. vka.
boolean
C2940579 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C1571583 (UMLS CUI [2])
C3653316 (UMLS CUI [3])
C1277289 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0018826 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Patients Appropriate Pradaxa | Patients Appropriate Vitamin K antagonists
Item
patients suitable for therapy with pradaxa as well as with vka.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2940579 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C3653316 (UMLS CUI [2,3])
dabigatran etexilate | Vitamin K antagonists
Item
treatment with dabigatranetexilat resp. vka follows summary of product characteristics.
boolean
C1571583 (UMLS CUI [1])
C3653316 (UMLS CUI [2])
Routine Diagnostic unchanged | Routine Treatment unchanged
Item
the usual routine in diagnostics and treatment will not be modified.
boolean
C0205547 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0205547 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
Qualification Vitamin K antagonists | Qualification Dabigatran etexilate
Item
only patients will be documented qualifying for vka-therapy as well as for dabigatranetexilat acc. to pradaxa® resp. vka summary of product characteristics.
boolean
C1709790 (UMLS CUI [1,1])
C3653316 (UMLS CUI [1,2])
C1709790 (UMLS CUI [2,1])
C1571583 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent before inclusion.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication General | Medical contraindication Special
Item
patients with general or special contraindications acc. to summary of product characteristics.
boolean
C1301624 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0205555 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial Without Interventional procedure | Interventional Study
Item
patients participating at the same time or within the last 30 days in another non-interventional study (nis) or interventional clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C3274035 (UMLS CUI [3])
Patient need for Anticoagulation Therapy | Exception Indication Atrial Fibrillation
Item
patients needing anticoagulative treatment for indications other than non-valvular atrial fibrillation.
boolean
C0686904 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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