ID

12760

Description

Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS); ODM derived from: https://clinicaltrials.gov/show/NCT00070655

Lien

https://clinicaltrials.gov/show/NCT00070655

Mots-clés

  1. 21/12/2015 21/12/2015 -
Téléchargé le

21 décembre 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Atrial Fibrillation NCT00070655

Eligibility Atrial Fibrillation NCT00070655

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecg-documented atrial fibrillation (af) and an indication for long-term vitamin k antagonist (vka) therapy based on the presence of at least one of the following risk factors:
Description

atrial fibrillation: vitamin k antagonist therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C1096489
1. previous ischemic stroke, transient ischemic attack (tia) or systemic embolism
Description

ischemic stroke; systemic embolism

Type de données

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0149876
2. hypertension requiring drug treatment
Description

hypertension treatment required

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332121
3. left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
Description

left ventricular ejection fraction; symptomatic congestive heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0742758
4. age >75 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
5. age between 65-75 years plus diabetes mellitus, or
Description

age; Diabetes Mellitus

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011849
6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (mi) or angina pectoris)
Description

age; symptomatic coronary artery disease

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1956346
written informed consent
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
legal lower age limitations (country specific)
Description

age Limitation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0449295
indication for vka other than af, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
Description

vitamin k antagonist therapy; Heart Valve Prosthesis

Type de données

boolean

Alias
UMLS CUI [1]
C1096489
UMLS CUI [2]
C0018825
transient af caused by a reversible disorder
Description

atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C0004238
active bleeding or high risk of bleeding
Description

active bleeding

Type de données

boolean

Alias
UMLS CUI [1]
C0019080
recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
Description

major surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
participation in another pharmacotherapeutic study within the prior 30 days
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
creatinine clearance <10 ml/min, severe hepatic disease, or bacterial endocarditis
Description

creatinine clearance; hepatic disease; bacterial endocarditis

Type de données

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0014121
uncontrolled hypertension: systolic blood pressure > 180 mm hg and/or diastolic blood pressure > 110 mm hg
Description

uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
pregnancy or childbearing potential without proper contraceptive measures
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Description

lactating

Type de données

boolean

Alias
UMLS CUI [1]
C2828358
any other contraindication listed in the labeling of warfarin or acenocoumarol
Description

contraindication Warfarin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031

Similar models

Eligibility Atrial Fibrillation NCT00070655

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
atrial fibrillation: vitamin k antagonist therapy
Item
ecg-documented atrial fibrillation (af) and an indication for long-term vitamin k antagonist (vka) therapy based on the presence of at least one of the following risk factors:
boolean
C0004238 (UMLS CUI [1])
C1096489 (UMLS CUI [2])
ischemic stroke; systemic embolism
Item
1. previous ischemic stroke, transient ischemic attack (tia) or systemic embolism
boolean
C0948008 (UMLS CUI [1])
C0149876 (UMLS CUI [2])
hypertension treatment required
Item
2. hypertension requiring drug treatment
boolean
C0020538 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
left ventricular ejection fraction; symptomatic congestive heart failure
Item
3. left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
boolean
C0428772 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
Age
Item
4. age >75 years
boolean
C0001779 (UMLS CUI [1])
age; Diabetes Mellitus
Item
5. age between 65-75 years plus diabetes mellitus, or
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
age; symptomatic coronary artery disease
Item
6. age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (mi) or angina pectoris)
boolean
C0001779 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age Limitation
Item
legal lower age limitations (country specific)
boolean
C0001779 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
vitamin k antagonist therapy; Heart Valve Prosthesis
Item
indication for vka other than af, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
boolean
C1096489 (UMLS CUI [1])
C0018825 (UMLS CUI [2])
atrial fibrillation
Item
transient af caused by a reversible disorder
boolean
C0004238 (UMLS CUI [1])
active bleeding
Item
active bleeding or high risk of bleeding
boolean
C0019080 (UMLS CUI [1])
major surgery
Item
recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
boolean
C0679637 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in another pharmacotherapeutic study within the prior 30 days
boolean
C2348568 (UMLS CUI [1])
creatinine clearance; hepatic disease; bacterial endocarditis
Item
creatinine clearance <10 ml/min, severe hepatic disease, or bacterial endocarditis
boolean
C0373595 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0014121 (UMLS CUI [3])
uncontrolled hypertension
Item
uncontrolled hypertension: systolic blood pressure > 180 mm hg and/or diastolic blood pressure > 110 mm hg
boolean
C1868885 (UMLS CUI [1])
Pregnancy
Item
pregnancy or childbearing potential without proper contraceptive measures
boolean
C0032961 (UMLS CUI [1])
lactating
Item
breastfeeding
boolean
C2828358 (UMLS CUI [1])
contraindication Warfarin
Item
any other contraindication listed in the labeling of warfarin or acenocoumarol
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial