ID

37589

Description

Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function; ODM derived from: https://clinicaltrials.gov/show/NCT01896297

Link

https://clinicaltrials.gov/show/NCT01896297

Keywords

Versions (1)
  1. 8/8/19 8/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01896297

English

Eligibility Atrial Fibrillation NCT01896297

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
Description

Atrial Fibrillation | Indication Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0003281
subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 ml/min by cockcroft-gault formula,
Description

Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2711451
male and female patients, age =18 years at entry
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to pradaxa (history of a serious hypersensitivity reaction to pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
Description

Medical contraindication Pradaxa | Hypersensitivity Serious Pradaxa | Hemorrhage | Mechanical heart valve prosthesis

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2940579
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2940579
UMLS CUI [3]
C0019080
UMLS CUI [4]
C3873910
creatinine clearance <15ml/min or patients with end stage renal disease on dialysis,
Description

Creatinine clearance measurement | Kidney Failure, Chronic | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0011946
creatinine clearance >30 ml/min,
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
Description

Premenopausal state | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Tubal Ligation | Transdermal patch as birth control method | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Barrier Contraception Double | Partner had vasectomy

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032961
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0520483
UMLS CUI [7]
C2135981
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0009905
UMLS CUI [10]
C1657106
UMLS CUI [11]
C1656586
UMLS CUI [12,1]
C0004764
UMLS CUI [12,2]
C0205173
UMLS CUI [13]
C0420842
patients who are participating in another drug study,
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patients who have participated in another drug study within 6 weeks,
Description

Study Subject Participation Status Previous | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0013230
patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
Description

Study Subject Participation Status | Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
any condition the investigator believes would not allow safe participation in the study,
Description

Condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
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Similar models

Eligibility Atrial Fibrillation NCT01896297

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Indication Anticoagulation Therapy
Item
subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 ml/min by cockcroft-gault formula,
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Age
Item
male and female patients, age =18 years at entry
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Pradaxa | Hypersensitivity Serious Pradaxa | Hemorrhage | Mechanical heart valve prosthesis
Item
contraindications to pradaxa (history of a serious hypersensitivity reaction to pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
boolean
C1301624 (UMLS CUI [1,1])
C2940579 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2940579 (UMLS CUI [2,3])
C0019080 (UMLS CUI [3])
C3873910 (UMLS CUI [4])
Creatinine clearance measurement | Kidney Failure, Chronic | Dialysis
Item
creatinine clearance <15ml/min or patients with end stage renal disease on dialysis,
boolean
C0373595 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance >30 ml/min,
boolean
C0373595 (UMLS CUI [1])
Premenopausal state | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Tubal Ligation | Transdermal patch as birth control method | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Barrier Contraception Double | Partner had vasectomy
Item
pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
boolean
C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0520483 (UMLS CUI [6])
C2135981 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C1657106 (UMLS CUI [10])
C1656586 (UMLS CUI [11])
C0004764 (UMLS CUI [12,1])
C0205173 (UMLS CUI [12,2])
C0420842 (UMLS CUI [13])
Study Subject Participation Status | Investigational New Drugs
Item
patients who are participating in another drug study,
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status Previous | Investigational New Drugs
Item
patients who have participated in another drug study within 6 weeks,
boolean
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Protocol Compliance Unlikely
Item
patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
boolean
C2348568 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Condition Study Subject Participation Status At risk
Item
any condition the investigator believes would not allow safe participation in the study,
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
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