ID

44406

Descripción

Clarification of Optimal Anticoagulation Through Genetics; ODM derived from: https://clinicaltrials.gov/show/NCT00839657

Link

https://clinicaltrials.gov/show/NCT00839657

Palabras clave

Versiones (2)
  1. 4/11/18 4/11/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Stroke NCT00839657

Inglés

Eligibility Stroke NCT00839657

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Stroke NCT00839657
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
willingness and ability to sign informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
able to be followed in outpatient ac clinic
Descripción

Ability Follow-up Outpatient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0029921
expected duration of warfarin therapy of at least 1 month
Descripción

Warfarin | Duration of therapy Expected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C0444921
UMLS CUI [2,2]
C1517001
ac management for the patient will be performed in-hospital and as an outpatient by clinicians that will adhere to the study dosing algorithms and dose titration plans
Descripción

Inpatient | Outpatient | Adherence Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2348563
target inr 2-3
Descripción

Target INR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272307
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently taking warfarin
Descripción

Warfarin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043031
prior warfarin therapy with known required stable dose
Descripción

Warfarin | Prior Therapy Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
clinician opinion that warfarin dosing needs to be adjusted for reasons not accounted for by dosing algorithm
Descripción

Warfarin | Dose Adjustment Required

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C2826232
UMLS CUI [2,2]
C1514873
abnormal baseline inr (off warfarin) (e.g., due to liver disease, antiphospholipid antibody)
Descripción

INR abnormal | Etiology Liver disease | Etiology Antiphospholipid Antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0580417
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0023895
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0162595
contraindication to warfarin treatment for at least 3 months
Descripción

Medical contraindication Warfarin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
life expectancy of less than 1 year
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
pregnant women or child-bearing women not using medically approved method of birth control (requires negative pregnancy test to exclude pregnancy in child-bearing women)
Descripción

Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy test negative

Tipo de datos

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]
C3831118
UMLS CUI [3,2]
C0427780
inability to follow-up on a regular basis with anticoagulation practitioners participating in the trial
Descripción

Follow-up Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
any factors likely to limit adherence to warfarin
Descripción

Factor Limiting Adherence Warfarin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1510802
UMLS CUI [1,4]
C0043031
cognitive or other causes of inability to provide informed consent or follow study procedures
Descripción

Impaired cognition Informed Consent Unable | Impaired cognition Protocol Compliance Unable | Cause Informed Consent Unable | Cause Protocol Compliance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C1299582
participating in another trial that prohibits participation in the coag trial or planned enrollment in such a trial within the first 6 months of warfarin therapy
Descripción

Study Subject Participation Status | Exclusion Participation Clinical Trial Specified

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205369
estimated blood loss of more than 1,000 cc requiring blood transfusions within 48 hours prior to randomization
Descripción

Blood Loss Amount | Blood Transfusion Required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0005841
UMLS CUI [2,2]
C1514873
genotype (cyp2c9 or vkorc1) known to participant from prior testing
Descripción

Study Subject Participation Status | CYP2C9 Genotype | VKORC1 Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1332829
UMLS CUI [2,2]
C0017431
UMLS CUI [3,1]
C1428184
UMLS CUI [3,2]
C0017431
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Similar models

Eligibility Stroke NCT00839657

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Stroke NCT00839657
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willingness and ability to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Ability Follow-up Outpatient
Item
able to be followed in outpatient ac clinic
boolean
C0085732 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
Warfarin | Duration of therapy Expected
Item
expected duration of warfarin therapy of at least 1 month
boolean
C0043031 (UMLS CUI [1])
C0444921 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Inpatient | Outpatient | Adherence Study Protocol
Item
ac management for the patient will be performed in-hospital and as an outpatient by clinicians that will adhere to the study dosing algorithms and dose titration plans
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C1510802 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Target INR
Item
target inr 2-3
boolean
C1272307 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Warfarin
Item
currently taking warfarin
boolean
C0043031 (UMLS CUI [1])
Warfarin | Prior Therapy Dose Stable
Item
prior warfarin therapy with known required stable dose
boolean
C0043031 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Warfarin | Dose Adjustment Required
Item
clinician opinion that warfarin dosing needs to be adjusted for reasons not accounted for by dosing algorithm
boolean
C0043031 (UMLS CUI [1])
C2826232 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
INR abnormal | Etiology Liver disease | Etiology Antiphospholipid Antibody
Item
abnormal baseline inr (off warfarin) (e.g., due to liver disease, antiphospholipid antibody)
boolean
C0580417 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0023895 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0162595 (UMLS CUI [3,2])
Medical contraindication Warfarin
Item
contraindication to warfarin treatment for at least 3 months
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of less than 1 year
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy test negative
Item
pregnant women or child-bearing women not using medically approved method of birth control (requires negative pregnancy test to exclude pregnancy in child-bearing women)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Follow-up Unable
Item
inability to follow-up on a regular basis with anticoagulation practitioners participating in the trial
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Factor Limiting Adherence Warfarin
Item
any factors likely to limit adherence to warfarin
boolean
C1521761 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C0043031 (UMLS CUI [1,4])
Impaired cognition Informed Consent Unable | Impaired cognition Protocol Compliance Unable | Cause Informed Consent Unable | Cause Protocol Compliance Unable
Item
cognitive or other causes of inability to provide informed consent or follow study procedures
boolean
C0338656 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Study Subject Participation Status | Exclusion Participation Clinical Trial Specified
Item
participating in another trial that prohibits participation in the coag trial or planned enrollment in such a trial within the first 6 months of warfarin therapy
boolean
C2348568 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
Blood Loss Amount | Blood Transfusion Required
Item
estimated blood loss of more than 1,000 cc requiring blood transfusions within 48 hours prior to randomization
boolean
C3163616 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0005841 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Study Subject Participation Status | CYP2C9 Genotype | VKORC1 Genotype
Item
genotype (cyp2c9 or vkorc1) known to participant from prior testing
boolean
C2348568 (UMLS CUI [1])
C1332829 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C1428184 (UMLS CUI [3,1])
C0017431 (UMLS CUI [3,2])
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