ID

37627

Descripción

Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion); ODM derived from: https://clinicaltrials.gov/show/NCT02100228

Link

https://clinicaltrials.gov/show/NCT02100228

Palabras clave

Versiones (1)
  1. 12/8/19 12/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de agosto de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Atrial Fibrillation NCT02100228

Inglés

Eligibility Atrial Fibrillation NCT02100228

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with non-valvular atrial fibrillation indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label.
Descripción

Atrial Fibrillation | Indication Electric Countershock | Initiation Anticoagulation Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013778
UMLS CUI [3,1]
C1704686
UMLS CUI [3,2]
C0003281
age ≥18 years (age ≥ 20 years for japan only).
Descripción

Age | Japan

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0022341
evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study.
Descripción

Informed Consent | Informed Consent Patient Representative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
the subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. (subject to irb/iec approval)
Descripción

Contact Person Alternate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C1523987
female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. a subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
Descripción

Childbearing Potential Sexually active Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization.
Descripción

Oral anticoagulants | Anticoagulants Parenteral

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1518896
contraindications to apixaban or usual care (eg, vka) in accordance with the approved local label.
Descripción

Medical contraindication Apixaban | Medical contraindication Standard of Care | Medical contraindication Vitamin K antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1831808
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2936643
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C3653316
severe haemodynamically compromised subjects requiring emergent cardioversion.
Descripción

Impairment Hemodynamic Severe | Requirement Emergency Electric Countershock

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221099
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013956
UMLS CUI [2,3]
C0013778
patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
Descripción

Mitral Stenosis Hemodynamic Significant | Prosthetic valve | Prosthetic valve biological | Valve Repair

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026269
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [2]
C0336548
UMLS CUI [3,1]
C0336548
UMLS CUI [3,2]
C0205460
UMLS CUI [4,1]
C1186983
UMLS CUI [4,2]
C4319951
conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic heart valve).
Descripción

Condition Requirement Chronic anticoagulation | Exception Atrial Fibrillation | Heart Valve Prosthesis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0694554
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004238
UMLS CUI [3]
C0018825
simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel, ticlopidine, prasugrel)
Descripción

Combined Modality Therapy | Aspirin | Thienopyridines | clopidogrel | Ticlopidine | prasugrel

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C0004057
UMLS CUI [3]
C2936588
UMLS CUI [4]
C0070166
UMLS CUI [5]
C0040207
UMLS CUI [6]
C1620287
pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1299582
participation in other studies involving investigational drug(s) (phases 1-4) within 30 days before the current study begins and/or during study participation. note: subjects cannot be randomized into this study more than once.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Descripción

Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Chronic disease Investigational New Drugs At risk | Chronic disease Interferes with Interpretation Research results | Chronic disease Study Subject Participation Status Inappropriate | Mental disorder Study Subject Participation Status At risk | Mental disorder Investigational New Drugs At risk | Mental disorder Interferes with Interpretation Research results | Mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal Investigational New Drugs At risk | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C0008679
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0459471
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C0008679
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C1548788
UMLS CUI [9,1]
C0004936
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C0004936
UMLS CUI [10,2]
C0013230
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C1548788
UMLS CUI [13,1]
C0438215
UMLS CUI [13,2]
C2348568
UMLS CUI [13,3]
C1444641
UMLS CUI [14,1]
C0438215
UMLS CUI [14,2]
C0013230
UMLS CUI [14,3]
C1444641
UMLS CUI [15,1]
C0438215
UMLS CUI [15,2]
C0521102
UMLS CUI [15,3]
C0459471
UMLS CUI [15,4]
C0683954
UMLS CUI [16,1]
C0438215
UMLS CUI [16,2]
C2348568
UMLS CUI [16,3]
C1548788
subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are bms/pfizer employees directly involved in the conduct of the trial.
Descripción

Member Research Personnel | Involvement with Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C2732579
Volver a la parte superior de la página

Similar models

Eligibility Atrial Fibrillation NCT02100228

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Indication Electric Countershock | Initiation Anticoagulation Therapy
Item
subjects with non-valvular atrial fibrillation indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label.
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
C1704686 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])
Age | Japan
Item
age ≥18 years (age ≥ 20 years for japan only).
boolean
C0001779 (UMLS CUI [1])
C0022341 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representative
Item
evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Contact Person Alternate
Item
the subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. (subject to irb/iec approval)
boolean
C0332158 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C1523987 (UMLS CUI [1,3])
Childbearing Potential Sexually active Contraceptive methods
Item
female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. a subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Protocol Compliance
Item
subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Oral anticoagulants | Anticoagulants Parenteral
Item
subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization.
boolean
C0354604 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
Medical contraindication Apixaban | Medical contraindication Standard of Care | Medical contraindication Vitamin K antagonists
Item
contraindications to apixaban or usual care (eg, vka) in accordance with the approved local label.
boolean
C1301624 (UMLS CUI [1,1])
C1831808 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C3653316 (UMLS CUI [3,2])
Impairment Hemodynamic Severe | Requirement Emergency Electric Countershock
Item
severe haemodynamically compromised subjects requiring emergent cardioversion.
boolean
C0221099 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
Mitral Stenosis Hemodynamic Significant | Prosthetic valve | Prosthetic valve biological | Valve Repair
Item
patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
boolean
C0026269 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0336548 (UMLS CUI [2])
C0336548 (UMLS CUI [3,1])
C0205460 (UMLS CUI [3,2])
C1186983 (UMLS CUI [4,1])
C4319951 (UMLS CUI [4,2])
Condition Requirement Chronic anticoagulation | Exception Atrial Fibrillation | Heart Valve Prosthesis
Item
conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic heart valve).
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0694554 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0018825 (UMLS CUI [3])
Combined Modality Therapy | Aspirin | Thienopyridines | clopidogrel | Ticlopidine | prasugrel
Item
simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel, ticlopidine, prasugrel)
boolean
C0009429 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C2936588 (UMLS CUI [3])
C0070166 (UMLS CUI [4])
C0040207 (UMLS CUI [5])
C1620287 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in other studies involving investigational drug(s) (phases 1-4) within 30 days before the current study begins and/or during study participation. note: subjects cannot be randomized into this study more than once.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Chronic disease Investigational New Drugs At risk | Chronic disease Interferes with Interpretation Research results | Chronic disease Study Subject Participation Status Inappropriate | Mental disorder Study Subject Participation Status At risk | Mental disorder Investigational New Drugs At risk | Mental disorder Interferes with Interpretation Research results | Mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal Investigational New Drugs At risk | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0008679 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0008679 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0008679 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1548788 (UMLS CUI [8,3])
C0004936 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0004936 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C0004936 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0004936 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
C0438215 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C1444641 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C1444641 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0459471 (UMLS CUI [15,3])
C0683954 (UMLS CUI [15,4])
C0438215 (UMLS CUI [16,1])
C2348568 (UMLS CUI [16,2])
C1548788 (UMLS CUI [16,3])
Member Research Personnel | Involvement with Completion of clinical trial
Item
subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are bms/pfizer employees directly involved in the conduct of the trial.
boolean
C0680022 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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