ID

34805

Beskrivning

Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02227550

Länk

https://clinicaltrials.gov/show/NCT02227550

Nyckelord

Versioner (1)
  1. 2019-01-30 2019-01-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 januari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02227550

Engelsk

Eligibility Atrial Fibrillation NCT02227550

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
i1. non-valvular af (ecg-documented) with a clinical indication for catheter ablation
Beskrivning

Atrial Fibrillation ECG | Heart Valve Involvement Absent | Indication Catheter ablation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C0018826
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0162563
i2. clinical indication to undergo catheter ablation on continuous anticoagulant therapy
Beskrivning

Indication Catheter ablation | Anticoagulant therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0162563
UMLS CUI [2]
C0150457
i3. presence of at least one of the chads2 stroke risk factors
Beskrivning

Cerebrovascular accident Risk factors Quantity CHADS2 score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C2585876
stroke or tia
Beskrivning

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
age ≥ 75 years,
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mm hg,
Beskrivning

Hypertensive disease | Treatment chronic Hypertensive disease | Patient need for Antihypertensive therapy Continuous | Blood pressure Resting

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0020538
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0585941
UMLS CUI [3,3]
C0549178
UMLS CUI [4,1]
C1271104
UMLS CUI [4,2]
C0035253
diabetes mellitus,
Beskrivning

Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
symptomatic heart failure (nyha ≥ ii).
Beskrivning

Heart failure Symptomatic New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
i4. age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
i5. provision of signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria
Beskrivning

Exclusion Criteria General

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
e1. any disease that limits life expectancy to less than 1 year
Beskrivning

Disease Limiting Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
e2. participation in another clinical trial, either within the past two months or still ongoing
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
e3. previous participation in axafa
Beskrivning

Study Subject Participation Status | Clinical Trial Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
e4. pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception (oral contraception or intra-uterine device) or sterile women can be randomised.
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods Absent | Exception Gender Contraceptive methods | Exception Oral contraception | Exception Intrauterine Devices | Exception Female sterility

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0079399
UMLS CUI [3,3]
C0700589
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0029151
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0021900
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0917730
e5. breastfeeding women
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
e6. drug abuse or clinically manifest alcohol abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
e7. any stroke within 14 days before randomisation
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
exclusion criteria related to a cardiac condition
Beskrivning

Exclusion Criteria Relationship Cardiac problem

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0262402
e8. valvular af (as defined by the focussed update of the esc guidelines on af, i.e. severe mitral valve stenosis, mechanical heart valve). furthermore, patients who underwent mitral valve repair are not eligible for axafa.
Beskrivning

Atrial Fibrillation Valve | Mitral Valve Stenosis Severe | Mechanical heart valve | Mitral valvuloplasty

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1186983
UMLS CUI [2,1]
C0026269
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0493527
UMLS CUI [4]
C0396849
e9. any previous ablation or surgical therapy for af
Beskrivning

Catheter ablation for atrial fibrillation Previous | Operative Surgical Procedures Previous Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0004238
e10. cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
Beskrivning

Cardiac ablation Indication Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162563
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1552551
e11. clinical need for "triple therapy" (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
Beskrivning

Patient need for Combined Modality Therapy | Clopidogrel | Aspirin | Oral anticoagulants

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0009429
UMLS CUI [2]
C0070166
UMLS CUI [3]
C0004057
UMLS CUI [4]
C0354604
e12. other contraindications for use of vka or apixaban
Beskrivning

Medical contraindication Vitamin K Antagonist | Medical contraindication Apixaban

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2267235
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1831808
exclusion criteria based on laboratory abnormalities
Beskrivning

Exclusion Criteria Relationship Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0438215
e13. severe chronic kidney disease with an estimated glomerular filtration rate (gfr) < 15 ml/min
Beskrivning

Chronic Kidney Disease Severe | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
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Similar models

Eligibility Atrial Fibrillation NCT02227550

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation ECG | Heart Valve Involvement Absent | Indication Catheter ablation
Item
i1. non-valvular af (ecg-documented) with a clinical indication for catheter ablation
boolean
C0004238 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0018826 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0162563 (UMLS CUI [3,2])
Indication Catheter ablation | Anticoagulant therapy
Item
i2. clinical indication to undergo catheter ablation on continuous anticoagulant therapy
boolean
C3146298 (UMLS CUI [1,1])
C0162563 (UMLS CUI [1,2])
C0150457 (UMLS CUI [2])
Cerebrovascular accident Risk factors Quantity CHADS2 score
Item
i3. presence of at least one of the chads2 stroke risk factors
boolean
C0038454 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2585876 (UMLS CUI [1,4])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Age
Item
age ≥ 75 years,
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease | Treatment chronic Hypertensive disease | Patient need for Antihypertensive therapy Continuous | Blood pressure Resting
Item
hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mm hg,
boolean
C0020538 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0020538 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0585941 (UMLS CUI [3,2])
C0549178 (UMLS CUI [3,3])
C1271104 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
Diabetes Mellitus
Item
diabetes mellitus,
boolean
C0011849 (UMLS CUI [1])
Heart failure Symptomatic New York Heart Association Classification
Item
symptomatic heart failure (nyha ≥ ii).
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Age
Item
i4. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
i5. provision of signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria General
Item
general exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Disease Limiting Life Expectancy
Item
e1. any disease that limits life expectancy to less than 1 year
boolean
C0012634 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Study Subject Participation Status
Item
e2. participation in another clinical trial, either within the past two months or still ongoing
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Specified
Item
e3. previous participation in axafa
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Exception Gender Contraceptive methods | Exception Oral contraception | Exception Intrauterine Devices | Exception Female sterility
Item
e4. pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception (oral contraception or intra-uterine device) or sterile women can be randomised.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0079399 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0029151 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0021900 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0917730 (UMLS CUI [6,2])
Breast Feeding
Item
e5. breastfeeding women
boolean
C0006147 (UMLS CUI [1])
Substance Use Disorders
Item
e6. drug abuse or clinically manifest alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Cerebrovascular accident
Item
e7. any stroke within 14 days before randomisation
boolean
C0038454 (UMLS CUI [1])
Exclusion Criteria Relationship Cardiac problem
Item
exclusion criteria related to a cardiac condition
boolean
C0680251 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0262402 (UMLS CUI [1,3])
Atrial Fibrillation Valve | Mitral Valve Stenosis Severe | Mechanical heart valve | Mitral valvuloplasty
Item
e8. valvular af (as defined by the focussed update of the esc guidelines on af, i.e. severe mitral valve stenosis, mechanical heart valve). furthermore, patients who underwent mitral valve repair are not eligible for axafa.
boolean
C0004238 (UMLS CUI [1,1])
C1186983 (UMLS CUI [1,2])
C0026269 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0493527 (UMLS CUI [3])
C0396849 (UMLS CUI [4])
Catheter ablation for atrial fibrillation Previous | Operative Surgical Procedures Previous Atrial Fibrillation
Item
e9. any previous ablation or surgical therapy for af
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Cardiac ablation Indication Any
Item
e10. cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
boolean
C0162563 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Patient need for Combined Modality Therapy | Clopidogrel | Aspirin | Oral anticoagulants
Item
e11. clinical need for "triple therapy" (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
boolean
C0686904 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2])
C0004057 (UMLS CUI [3])
C0354604 (UMLS CUI [4])
Medical contraindication Vitamin K Antagonist | Medical contraindication Apixaban
Item
e12. other contraindications for use of vka or apixaban
boolean
C1301624 (UMLS CUI [1,1])
C2267235 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1831808 (UMLS CUI [2,2])
Exclusion Criteria Relationship Laboratory test result abnormal
Item
exclusion criteria based on laboratory abnormalities
boolean
C0680251 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
Chronic Kidney Disease Severe | Estimated Glomerular Filtration Rate
Item
e13. severe chronic kidney disease with an estimated glomerular filtration rate (gfr) < 15 ml/min
boolean
C1561643 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
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